Reported trial results for Breast Cancer

Every Breast Cancer trial Voxsanity tracks that has reported results to a public registry, newest first. These trials have finished, so they are not recruiting. Not medical advice.

186 trials have reported results.

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

NCT04216472 · results posted 7 July 2026

According to the results reported on ClinicalTrials.gov, this trial looked at a combination of two medicines — alpelisib and nab-paclitaxel — given to breast cancer patients before surgery (this is called "neoadjuvant" treatment, meaning treatment given before an operation). The trial was measuring something called a "pathological complete response," which means no cancer can be found in the tissue removed during surgery. A total of 6 people were enrolled, 5 completed the study, and 1 did not finish. The reported data shows that out of the 5 participants who completed the study, 1 person had no detectable cancer remaining in the surgical tissue (a pathological complete response), while 4 did not meet that outcome. Because this trial included a very small number of people — just 6 enrolled in total — the reported numbers are very limited in what they can tell us. It is also worth noting that only one outcome measure was reported in the submitted data; no secondary outcome results appear to have been submitted to ClinicalTrials.gov for this trial, so those figures cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03289364 · results posted 28 April 2026

According to the results reported on ClinicalTrials.gov, this trial looked at whether Penguin Cold Caps — devices worn during chemotherapy to cool the scalp — could reduce or prevent chemotherapy-related hair loss. Twelve people took part, ten completed the study, and two did not finish. Participants' hair loss was assessed 30 days after completing chemotherapy using a grading scale called the Dean's alopecia scale, which rates hair loss from Grade 0 (no hair loss) through to Grade 4 (more than 75% hair loss). The main goal was to find out how many participants lost less than 50% of their hair (a score of Grade 0, 1, or 2 on that scale). The reported data shows that, of the ten participants assessed for the main outcome, four were recorded at Grade 0 (no hair loss), three at Grade 1 (up to 25% hair loss), and three at Grade 2 (more than 25% but up to 50% hair loss). For a secondary measure, participants were asked whether they felt the cold cap experience was "worth it." The reported data shows that out of ten participants who responded, nine, ten, eight, five, and five participants answered positively across the five questions in that survey (the exact wording of each individual question was not included in the reported data). Participants also completed two quality-of-life questionnaires. The reported data shows average scores across several areas ranging from roughly 33 to 84 out of 100 on one questionnaire, and scores of approximately 42 to 65 out of 100 on the breast cancer-specific questionnaire, with a body image disturbance score of around 4 out of 30 — though the specific sub-scale labels for each individual score were not included in the data as reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05654623 · results posted 3 February 2026

According to the results reported on ClinicalTrials.gov, this trial (NCT05654623) compared two treatments — vepdegestrant (also called ARV-471) and fulvestrant — in people with a type of breast cancer. A total of 313 people were assigned to the vepdegestrant group and 311 to the fulvestrant group, making 624 participants in all. The trial's main focus was on something called "progression-free survival" (PFS) — that is, how long participants went without their cancer visibly growing or spreading, or dying, based on independent scans and imaging reviews. This was measured for all participants combined, and also separately for those whose cancer had a specific gene change known as an ESR1 mutation. The reported data shows that, among all participants, the median time without disease progression was 3.7 months in the vepdegestrant group and 3.6 months in the fulvestrant group. (Median means half the participants in each group had an event before that time, and half after.) Among the smaller group who had an ESR1 mutation, the reported median progression-free survival was 5.0 months for vepdegestrant and 2.1 months for fulvestrant. For secondary outcomes, the reported data shows that among participants with measurable disease at the start, about 10.9% in the vepdegestrant group and 3.6% in the fulvestrant group had their tumour shrink meaningfully (called an "objective response"). A broader measure — the proportion of participants whose cancer shrank or stayed stable for at least 24 weeks (called "clinical benefit rate") — was reported as 34.3% for vepdegestrant and 28.7% for fulvestrant. The overall survival figures (how long participants lived overall) were listed as secondary outcomes but no numbers were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT03879577 · results posted 21 January 2026

According to the results reported on ClinicalTrials.gov, this trial enrolled 53 people, all of whom received a combination of two medicines — Taxotere (a chemotherapy) and Trastuzumab (a targeted therapy) — before surgery for breast cancer. This type of treatment given before surgery is called "neoadjuvant" therapy. The main thing the trial was measuring was how many participants showed a "complete pathologic response," meaning that when doctors examined the removed tissue under a microscope after surgery, no invasive cancer cells could be found in the breast or nearby lymph nodes. Forty-seven of the 53 participants completed the study. The reported data shows that out of the 53 participants, 25 showed a complete pathologic response as defined by the trial. For a secondary measure looking at side effects and unwanted reactions, the reported data shows that all 47 participants who completed the study experienced at least one adverse event (an unwanted reaction or health change that was recorded during the trial). Two other secondary outcomes — how long participants went without their disease getting worse (progression-free survival) and how long a response lasted (duration of response) — were not reported in the submitted data. The trial also tracked participants' self-reported overall health and quality of life using a standard questionnaire scored from 1 (very poor) to 7 (excellent). The reported data shows small average decreases from the starting point: overall health changed by −0.57 and overall quality of life by −0.49 on that scale by the end of treatment, meaning scores were slightly lower than at the beginning on average. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT04534010 · results posted 17 December 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04534010) enrolled 6 participants, all of whom were patients receiving NAC (nipple-areola complex) grafts. The trial was measuring how well these grafts healed over time, specifically looking at whether the graft tissue reached what the researchers defined as "complete healing" — meaning more than 99% of the graft surface had re-formed a skin layer. Of the 6 people who started the trial, 4 completed it, and 2 did not complete it (the reasons were not detailed in the reported data). The reported data shows that the primary outcome measured was the number of grafts that achieved complete healing. The results list a value of 8 grafts across the measurement points recorded. It is worth noting that the number of grafts (8) is higher than the number of participants (6), which likely reflects that some participants may have had more than one graft assessed, though this is not explicitly explained in the submitted data. Healing was assessed visually by the treating surgeon and an independent reviewer using standardised photographs and a scoring scale rating things like skin re-formation and overall healing appearance. The reported data shows only this single primary outcome measure was submitted to ClinicalTrials.gov, and no secondary outcome measure results were included in the data provided. Because the trial was very small — involving only 6 people — the numbers on their own are limited in what they can tell us more broadly. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05757427 · results posted 26 November 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT05757427) involved 73 people who received a breast scan using a device called Wavelia MWBI (Microwave Breast Imaging). Of those, 62 people completed the trial and 11 did not finish. The trial was measuring how well the Wavelia MWBI scan could detect breast lesions (abnormal areas in the breast, which can be either cancerous or non-cancerous), and how accurately it could estimate their size compared to ultrasound measurements. The reported data shows that, for the primary goal of detecting breast lesions, the device correctly identified 56 out of the dominant lesions assessed (both cancerous and non-cancerous combined — the total number of lesions assessed was not separately reported in the data provided). For sizing, the reported data shows the Wavelia scan measured lesions at an average of 1.6 mm smaller than the size recorded by ultrasound. In a separately reported analysis looking only at participants who did not have a biopsy clip (a small marker sometimes left in the breast after a tissue sample is taken), 15 participants were included in that sub-group. Regarding adverse events (unwanted or unexpected experiences during the trial), the reported data shows that 4 participants experienced an adverse event of some kind; however, a further breakdown of the nature or seriousness of those events was not reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04305496 · results posted 27 October 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04305496) enrolled a total of 842 people across two groups — a Global Cohort (708 participants) and a China Cohort (134 participants). In each cohort, participants were randomly assigned to receive either capivasertib combined with fulvestrant, or a placebo combined with fulvestrant. The trial was primarily measuring **progression-free survival** — that is, how long participants went before their cancer showed signs of growing or spreading (called "progression"), or before they died from any cause. The reported data shows that, in the overall Global Cohort population, the median time before cancer progression or death was 7.2 months for those in the capivasertib + fulvestrant group, compared with 3.6 months for those in the placebo + fulvestrant group. Among a sub-group of participants whose tumours had specific genetic changes (called the "altered population"), the reported figures were 7.3 months versus 3.1 months respectively. For the China Cohort, the reported median figures were 6.9 months for the capivasertib + fulvestrant group and 2.8 months for the placebo + fulvestrant group. The reported data also shows the percentage of participants still progression-free at various time points — for example, in the overall Global Cohort at one time point, around 51.8% of the capivasertib group and 32.0% of the placebo group had not yet progressed. It is worth noting that most participants in both groups did not complete the trial — the majority left early, most commonly because their cancer progressed or for other reasons recorded by the researchers. The data as submitted does not provide a breakdown of exactly why each person left the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT06133348 · results posted 14 October 2025

According to the results reported on ClinicalTrials.gov, this trial tested a programme called PRISM with 43 participants. The main question the trial was trying to answer was whether the programme was *feasible* — meaning, could it realistically be run and completed by enough people? The researchers set a target of at least 70% of participants finishing all sessions and completing surveys before and after the programme. Of the 43 people who started, 33 completed the programme and 10 did not. The reported data shows that the 33 completers met the pre-set feasibility target (roughly 77%, above the 70% threshold). For the secondary measures, participants filled out three standard questionnaires rating how acceptable, appropriate, and feasible they found the programme on a scale of 1 to 5 (where scores above 4 were considered positive). The reported scores were 4.5 for acceptability, 4.5 for appropriateness, and 4.6 for feasibility. The trial also measured resilience using a scale scored 0–40; the reported data shows an average score of 28.5 before the programme and 31.8 afterwards. A measure of post-traumatic growth — broadly, positive personal changes following difficult experiences — uses a scale of 0–105, and the reported averages were 57.4 before and 67.8 after. Two sub-sections of that same measure also showed differences: a "personal strength" sub-scale (0–20) went from 10.9 to 13.2, and a "new possibilities" sub-scale (0–25) went from 11.0 to 14.5. It is worth noting that this trial had no comparison group, so the reported numbers reflect only the one group who received the PRISM programme. The data does not allow a direct comparison with people who did not receive it. Whether these figures are meaningful in a broader sense is a question for healthcare professionals to interpret. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04958785 · results posted 3 October 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04958785) enrolled 92 participants across five groups. It tested two different drug combinations involving magrolimab — one paired with a chemotherapy drug called nab-paclitaxel or paclitaxel, and another paired with a drug called sacituzumab govitecan — in people with a type of breast cancer. The trial had an initial safety check phase (called a "safety run-in") followed by a larger Phase 2 portion. Notably, zero participants in any group were recorded as having "completed" the study, meaning all participants exited before formal completion, though the data does not explain individual reasons for this. The reported data shows that in the safety run-in phase, 0% of participants in either drug combination group experienced what the trial defined as a "dose-limiting toxicity" — that is, a serious side effect severe enough to limit the dose. However, 100% of participants in both safety run-in groups experienced at least one "treatment-emergent adverse event" (meaning any new or worsening medical issue that arose after starting treatment), and all participants also showed at least one worsening laboratory test result during the study. For the main Phase 2 portion comparing magrolimab plus chemotherapy against chemotherapy alone, the reported median "progression-free survival" — meaning the estimated midpoint time before cancer worsened or a participant died — was 13.9 months for the magrolimab combination group and 10.0 months for the chemotherapy-only group. In terms of tumour shrinkage responses, 35.7% of participants in the magrolimab combination arm and 21.4% in the chemotherapy-only arm were reported to have had a confirmed response. For the separate sacituzumab govitecan combination groups, the reported response rates were 30.8% (safety run-in group) and 38.1% (Phase 2 group). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01703754 · results posted 28 August 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT01703754) tested a combination of an investigational gene therapy called Ad-RTS-hIL-12 together with a companion drug called Veledimex, given at three different daily doses (80 mg, 100 mg, or 140 mg), in people with a type of cancer. A total of 12 participants started the trial across the three dose groups — 7 in the 140 mg group, 4 in the 100 mg group, and 1 in the 80 mg group. The trial was primarily measuring how many participants experienced unwanted medical events (called adverse events) after starting treatment, and also whether participants' disease had not worsened by 16 weeks after their first dose. The reported data shows that when it came to unwanted medical events, every participant in each group who started the trial experienced at least one treatment-emergent adverse event — that is, all 7 in the 140 mg group, all 4 in the 100 mg group, and the 1 participant in the 80 mg group. Regarding the 16-week progression-free survival measure (meaning their disease had not visibly worsened and they had not died by that point), the reported data shows 2 out of 7 participants in the 140 mg group, 1 out of 4 in the 100 mg group, and 0 out of 1 in the 80 mg group met this measure. For a secondary measure looking at how long until disease progression, the reported median figures were 94 days for the 140 mg group, 64 days for the 100 mg group, and 1 day for the single participant in the 80 mg group. Other secondary measurements, including tumour response assessments and immune cell activity in the blood, were also reported for small numbers of participants, though the very small group sizes — particularly just one person in the 80 mg group — mean the reported figures represent individual cases rather than a broader pattern. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04862585 · results posted 20 August 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04862585) enrolled 98 people in total — 50 in one group who received the chemotherapy drug paclitaxel along with pre-medications (drugs given beforehand to try to prevent allergic-type reactions), and 48 in a second group who received paclitaxel without those pre-medications. The trial was primarily measuring how many people in each group had a moderate-to-severe infusion reaction — that is, an allergic-type response during the drip — serious enough to need emergency rescue medicines injected to treat it, looking at the first two doses of paclitaxel. The reported data shows that, for the main outcome, zero out of 50 participants in the pre-medication group had a reaction of that severity requiring rescue treatment, compared with one out of 48 participants in the no-pre-medication group. The trial also measured quality of life using an 11-point scale (where 0 means no problem and 10 means the worst possible), focusing on two specific side effects sometimes linked to pre-medications: unwanted appetite increase and skin rash. The reported data shows that, for unwanted appetite increase, the pre-medication group scored a worst average of 2.5 and the no-pre-medication group scored 1.0. For skin rash, the worst average scores were 3.3 (pre-medication group) versus 2.3 (no-pre-medication group). Changes from the starting point were also recorded: appetite change averaged 1.7 in the pre-medication group and 0.5 in the no-pre-medication group, while rash change averaged 2.9 versus 1.9. Several other planned measurements — including symptom differences, weight changes, and requests to restart pre-medications — were listed in the trial design but no numerical results were reported for those outcomes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04740918 · results posted 8 August 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04740918) enrolled 96 people in total — 50 in one group who received a medicine called trastuzumab emtansine plus a placebo (a dummy treatment), and 46 in a second group who received trastuzumab emtansine plus a second medicine called atezolizumab. The trial was measuring two main things: how long participants went without their cancer growing or spreading (called progression-free survival, or PFS), and how long participants lived overall (overall survival, or OS). It also looked at a number of secondary measures, including how many participants' tumours shrank, and for how long. The reported data shows that for the main measure of how long participants went without disease progression, the midpoint figure (meaning half of participants reached this point sooner and half later) was 7.52 months in the placebo group and 8.61 months in the atezolizumab group. For overall survival, the midpoint figure was not yet reached in either group at the time the data was collected, so a final number was not reported. Looking at the secondary measures, the reported data shows that around 49% of participants in the placebo group and 53.3% in the atezolizumab group had their tumours shrink to a meaningful degree. Among those whose tumours did shrink, the midpoint figure for how long that shrinkage lasted was 8.21 months in the placebo group and 15.57 months in the atezolizumab group. For the smaller subgroup of participants who had cancer that had spread to the brain at the start of the trial, the midpoint progression-free survival figure was 7.69 months in the placebo group and 4.78 months in the atezolizumab group; overall survival figures for this subgroup were also not yet reached and therefore not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04256512 · results posted 28 July 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 94 participants, all of whom were assigned to use Elasto Gel Therapy Mittens and Foot Wraps — a type of cooling glove and foot wrap worn during chemotherapy. The trial was measuring how many participants developed chemotherapy-induced peripheral neuropathy (CIPN), which is a condition involving tingling, numbness, or pain in the hands and feet that can occur as a side effect of some chemotherapy treatments. Ninety-three of the 94 participants completed the study, with one person not completing it. The reported data shows that the number of participants recorded as experiencing CIPN was measured at multiple points during the study. The figures reported were 41 participants, 30 participants, and 25 participants across the different measurement time points. It is worth noting that the data as submitted does not clearly label which time point each number corresponds to, so it is not possible to explain the exact order or timing of these measurements beyond what has been reported. It is also important to note that this trial did not include a comparison group (such as a group using no mittens or wraps), which means the reported numbers describe what was observed in one group only, without a direct comparison. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04915755 · results posted 16 July 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04915755) enrolled 40 people in total — 18 received niraparib and 22 received a placebo (a dummy treatment with no active ingredient). The trial was primarily measuring safety-related observations, including how many participants experienced adverse events (unwanted medical occurrences during the study), serious adverse events, events leading to death, and events that caused changes to their dose or led them to stop treatment altogether. The trial also tracked participants' general functioning levels and changes in blood test results over time. The reported data shows that all 18 participants in the niraparib group and 17 out of 22 in the placebo group experienced at least one adverse event during the study. Serious adverse events were reported in 5 people in the niraparib group and 1 person in the placebo group. No participants in either group died due to an adverse event during treatment. In the niraparib group, 10 participants had their dose reduced or interrupted due to an adverse event, and 11 had a delay in treatment; in the placebo group, these numbers were 0 and 1 respectively. No participants in either group permanently stopped treatment due to an adverse event. Regarding blood test results, the reported data shows various shifts — both increases and decreases from starting levels — across both groups, with the specific numbers varying by test type. Four participants in the niraparib group and 6 in the placebo group completed the study in full. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04975308 · results posted 11 July 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04975308) enrolled 874 participants across three groups: 331 people received imlunestrant alone (Arm A), 330 received a hormone therapy chosen by their doctor (Arm B), and 213 received imlunestrant combined with another drug called abemaciclib (Arm C). The trial was primarily measuring "progression-free survival" — that is, how long, in months, participants went without their cancer growing or spreading, or without dying. A key sub-group analysis also looked separately at participants whose tumours had a specific gene change called an ESR1 mutation. The reported data shows the following for the main "progression-free survival" figures (these are median values — meaning half of participants reached this point sooner, half later): When comparing imlunestrant alone (Arm A) against the doctor's choice of hormone therapy (Arm B) across all participants, the reported median times were 5.55 months and 5.52 months respectively. In the sub-group with the ESR1 gene change, the reported figures were 5.49 months for imlunestrant alone and 3.84 months for the doctor's choice therapy. When comparing the combination of imlunestrant plus abemaciclib (Arm C) against imlunestrant alone (Arm A), the reported median times were 9.36 months versus 5.49 months. A separate review by an independent panel (not the treating doctors) reported somewhat higher figures: 9.23 months vs 7.36 months for Arms A and B, and 14.52 months vs 9.23 months for Arms C and A. The reported data also shows that roughly 10.3% of participants in Arm A and 6.4% in Arm B had their tumour shrink or disappear, as assessed by their treating doctor. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT04739761 · results posted 16 May 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04739761) enrolled 504 people in total — 241 in Cohort 1 (participants who did not have brain metastases, meaning cancer that had spread to the brain, at the start of the trial) and 263 in Cohort 2 (participants who did have brain metastases at the start). All participants received a medicine called trastuzumab deruxtecan (T-DXd). The trial was measuring two main things: how many people in Cohort 1 had their tumours shrink or disappear, and how many people in Cohort 2 were still alive and free of disease worsening after 12 months. The reported data shows that in Cohort 1, 62.7% of participants had a confirmed reduction or disappearance of their tumour, as assessed by an independent review using standard imaging criteria. In Cohort 2, 61.6% of participants were reported to be alive and without their disease worsening at the 12-month mark. As a secondary (additional) measure, 51.7% of Cohort 2 participants also had a confirmed tumour reduction or disappearance. The reported data also shows that approximately 90.6% of Cohort 1 participants and 90.3% of Cohort 2 participants were alive at 12 months. For two other secondary measures — how long responses lasted (duration of response) and how long before the disease progressed (time to progression) — the data was not reported in the submitted results for either cohort. It is also worth noting that the number of participants recorded as having "completed" the trial was relatively small (30 in Cohort 1 and 34 in Cohort 2), with the majority recorded as not having completed it, though the reasons for this were not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03183050 · results posted 30 April 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT03183050) involved 88 participants who all received something called a QPL (a question prompt list — a tool designed to help patients ask questions during medical consultations). The trial was measuring participants' knowledge related to genetic testing and treatment options, for example in the context of breast cancer. Of the 88 people who started, 65 completed the study, and 23 did not finish. The reported data shows that knowledge was measured using a combined score covering two areas: understanding of genetic testing (scored out of 12) and understanding of treatment options (scored out of 5), giving a total possible score of 17. A higher score meant greater knowledge. According to the results reported on ClinicalTrials.gov, the average total knowledge score among participants was 12.36 out of 17. Because there was only one group in this trial (everyone received the QPL), there is no comparison group score reported to set alongside this figure. No secondary outcome measure data was included in the submitted results. It is worth noting that the reported data does not include information broken down by the testing and treatment sub-scores separately, and no comparison to a control group or a pre-intervention score was reported in the structured data submitted. This means it is not possible to draw conclusions from these numbers alone about any change in knowledge over time. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT04494425 · results posted 2 April 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04494425) enrolled 866 people in total — 436 assigned to a treatment called T-DXd and 430 assigned to standard chemotherapy. Participants had a type of breast cancer described as HER2-low (meaning the cancer cells carry a small amount of a particular protein called HER2). The trial's main goal was to measure how long participants went without their cancer growing or spreading — a period called "progression-free survival" — and it also tracked how long participants lived overall, as well as how many showed a measurable shrinkage in their tumour. The reported data shows that, for the main outcome in the hormone receptor-positive, HER2-low group, the median progression-free survival (that is, the middle point in time at which half the participants had experienced disease progression or death) was 13.2 months for the T-DXd group compared with 8.1 months for the chemotherapy group. For overall survival (how long participants lived from the point of joining the trial), the reported median was 28.9 months in the T-DXd group and 27.1 months in the chemotherapy group, in that same patient subgroup. When looking at all participants enrolled regardless of subgroup, the reported overall survival medians were 28.9 months for T-DXd and 27.4 months for chemotherapy. Regarding tumour response — the proportion of participants whose tumour shrank by a meaningful amount — the reported figures were approximately 60% for T-DXd and around 38–40% for chemotherapy, depending on whether the assessments were made by an independent review panel or the treating doctors. The data shows that zero participants were recorded as having "completed" the study, which likely reflects how the trial's completion milestone was defined rather than meaning no one finished treatment; the full context for this was not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT00971087 · results posted 26 February 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 3,521 people undergoing breast cancer screening, and all 3,521 completed the study. The trial was comparing two types of mammography imaging: a combined 3D-plus-synthesised-2D approach (referred to as "3D + s2D") against standard 2D digital mammography ("2D FFDM"). The main thing being measured was how well each imaging type performed at distinguishing between scans that did and did not show cancer, using a standard scoring method called the "area under the curve" (AUC) — a proportion scored from 0 to 1, where a higher number indicates better discrimination between cancer and non-cancer cases. The reported data shows that for the main measurement, the 3D + s2D approach scored 0.907 and the standard 2D approach scored 0.867. For a secondary measurement looking only at women with denser breast tissue (which can make imaging more challenging), the reported scores were 0.893 for 3D + s2D and 0.848 for 2D FFDM. The trial also tracked the rate at which people without cancer were nonetheless called back for further assessment — what is sometimes called a "false alarm" rate. The reported data shows this rate was 54.6% for the 3D + s2D group and 67.2% for the standard 2D group. It is important to note that these numbers describe what was observed and recorded in this specific study, under the particular conditions of the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03222856 · results posted 19 February 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 44 people with a specific type of advanced breast cancer (hormone receptor-positive, HER2-negative metastatic breast cancer) who had already received certain prior chemotherapy treatments. All 44 participants received a combination of two medicines — pembrolizumab and eribulin. Of the 44 who started, 37 completed the trial and 7 did not. The trial was primarily measuring something called the "clinical benefit rate" — that is, how many participants either saw their tumours shrink or had their disease remain stable for at least 24 weeks. The reported data shows that 25 out of 44 participants met the definition of clinical benefit (tumour shrinkage or stable disease for at least 24 weeks). Among participants whose tumours tested positive for a protein called PD-L1 (a marker found on some cancer cells), 9 participants showed clinical benefit. The reported data also shows that, on average, participants went approximately 6 months before their disease progressed (got worse), while those with PD-L1-positive tumours went approximately 5.3 months. For overall survival — meaning how long participants lived from the start of the study — the reported figure was approximately 14.2 months for all participants and approximately 13.6 months for those with PD-L1-positive tumours. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02386371 · results posted 6 February 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT02386371) enrolled 66 people who had experienced a local return of breast cancer after earlier breast-conserving treatment. All participants received a second round of breast-conserving surgery combined with intraoperative radiotherapy — that is, a single dose of radiation delivered directly to the surgical site during the operation. The trial's main goal was to assess how well patients tolerated this approach, specifically by looking at a tissue-hardening side effect called fibrosis at 12 months after treatment. Fifty-three participants completed the study, and 13 did not. The reported data shows that, for the primary measure, 34 out of the participants were recorded as having a lower fibrosis grade (grade 0–1, considered the better outcomes on the scale used), while 19 were recorded at grade 2 or above (the worse outcomes on that scale). For side effects tracked as secondary measures, the reported data shows small numbers of early complications — for example, 4 participants recorded with haematoma (a collection of blood under the skin) and 18 with lymphorrhoea (leakage of lymph fluid). Various later side effects were also recorded across participants, including skin-related changes, though the data as submitted does not clearly label every individual figure to a specific side effect category. The reported data also shows that, of those followed up: 2 participants experienced a local return of cancer and 51 did not; 1 participant had a distant (metastatic) return and 52 did not; 9 participants had any type of relapse and 44 did not; and 6 participants had died by the time results were reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03482557 · results posted 9 January 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 132 participants, all of whom completed the study. The trial was comparing three different breast imaging methods — contrast-enhanced spectral mammography (CESM, a type of mammogram using a contrast dye), standard breast MRI (a magnetic resonance scan), a shorter "abbreviated" version of breast MRI, and conventional 2D mammography — to see how well each method could identify breast cancer. Radiologists reviewed the scans and rated the likelihood of cancer in each case. The reported data shows the results using a measure called "area under the curve" (or AUC), which is a score between 0 and 1 that reflects how accurately a test distinguishes between people with and without cancer — a score of 1 would mean perfect accuracy. For the primary outcome, comparing CESM with full breast MRI, both methods returned a reported AUC score of 0.91. For the first secondary outcome, comparing CESM with abbreviated MRI, the reported scores were 0.906 for CESM and 0.894 for abbreviated MRI. For the second secondary outcome, comparing CESM with conventional 2D mammography, the reported scores were 0.906 for CESM and 0.788 for 2D mammography. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03673306 · results posted 13 December 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 4,732 women who had previously been diagnosed with breast cancer. They were divided into two groups: 659 women who became pregnant after their breast cancer diagnosis (the "Pregnant Cohort") and 4,073 women who did not become pregnant after their diagnosis (the "Non-pregnant Cohort"). The trial was measuring two main things: how many women became pregnant after their breast cancer diagnosis, and how long women in each group went without their cancer returning or worsening (called "disease-free survival"). It also tracked deaths related to breast cancer and deaths from any cause. The reported data shows that, when looking at disease-free survival, both groups had very similar rates — around 5.44 events per 100 person-years in the pregnant group and 5.45 events per 100 person-years in the non-pregnant group (a "person-year" is a way of counting time that accounts for how long each person was followed in the study). For the overall group of women in the study, the reported data shows that by 10 years, approximately 22% had gone on to become pregnant after their breast cancer diagnosis. For the secondary outcomes, 35 women in the pregnant group and 523 women in the non-pregnant group had a breast cancer-specific death recorded, while 39 women in the pregnant group and 570 women in the non-pregnant group died from any cause. No further breakdown of these figures was reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03487666 · results posted 3 December 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03487666) enrolled 45 people in total — 15 in each of three groups. One group received a drug called nivolumab (Arm A), one received a drug called capecitabine (Arm B), and one received both drugs together (Arm C). The trial was primarily measuring changes in something called the "Peripheral Immunoscore" (PIS) — a scoring system that tracks certain immune cells in the blood to give an overall picture of immune activity. A positive change in this score was defined as suggesting increased immune activity, and a negative change as suggesting decreased immune activity. The reported data shows that at the six-week mark (the main measurement point), the nivolumab-only group had an average PIS change of approximately +31%, the capecitabine-only group had a change of approximately −22%, and the combination group had a change of approximately +32%. At twelve weeks, the reported changes were approximately +33% for nivolumab alone, −16% for capecitabine alone, and +19% for the combination group. For serious unwanted effects (graded 3 or 4 out of 4 on a standard medical scale, where grade 4 is the most severe), the reported data shows 2 grade-3 events in the nivolumab group, 8 in the capecitabine group, and 3 in the combination group; no grade-4 events were recorded in any group. The reported average time without invasive disease returning was approximately 16.75 months for nivolumab alone, 16.04 months for capecitabine alone, and 21.37 months for the combination group. The reported data also shows that circulating tumour DNA — tiny fragments of cancer-related DNA detectable in the blood — was tracked in a subset of participants at three time points. At the start of the trial, 6, 4, and 4 participants had detectable levels in Arms A, B, and C respectively. By week 6, those numbers were 6, 2, and 1, and by week 12 they were 6, 3, and 1. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03901339 · results posted 21 October 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03901339) enrolled 272 people in the sacituzumab govitecan group and 271 people in the comparator group, which received a treatment chosen by their doctor (called "Treatment of Physician's Choice"). The trial was measuring how long participants went without their cancer growing or spreading (called progression-free survival), how long they lived overall, and a number of other related measures such as how many people's cancer shrank, how long that shrinkage lasted, and how many people experienced any meaningful benefit from treatment. The reported data shows that, for the main measure — the time until the cancer grew or the person died — the median (the middle value in the group, where half did better and half did worse) was 5.5 months in the sacituzumab govitecan group and 4.0 months in the doctor's-choice group, as assessed by an independent review panel. For overall survival, the reported median was 14.5 months in the sacituzumab govitecan group compared with 11.2 months in the doctor's-choice group. Regarding tumour shrinkage (called objective response rate), the reported data shows that approximately 21.3% of participants in the sacituzumab govitecan group had their cancer shrink to a meaningful degree, compared with 14.0% in the doctor's-choice group, based on independent review. The reported median duration of that shrinkage was 8.1 months versus 5.6 months respectively. For a broader measure called clinical benefit rate — which also counted people whose cancer stayed stable for at least six months — the reported figures were 33.8% for sacituzumab govitecan and 22.1% for the doctor's-choice group. The data also notes that no participants were recorded as having "completed" the study, meaning all participants had either left the trial or it had concluded before formal completion was recorded in this way. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04191499 · results posted 9 October 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04191499) enrolled 325 people in total — 161 in one group and 164 in the other. Participants were randomly assigned to receive either a combination of three medicines (inavolisib, palbociclib, and fulvestrant, referred to here as Inavo+Palbo+Fulv) or a similar combination where inavolisib was replaced by a placebo — an inactive dummy treatment (Pbo+Palbo+Fulv). The trial's main goal was to measure "progression-free survival" (PFS), which is the length of time from when a participant joined the trial until their cancer showed signs of growing or spreading, or until they died — whichever came first. The reported data shows that none of the 325 participants had formally "completed" the study by the time results were submitted, meaning the trial was still ongoing or had ended early for all participants. The reported data shows that the median PFS — meaning the point in time by which half the participants in each group had experienced disease progression or death — was 15 months in the Inavo+Palbo+Fulv group and 7.3 months in the Pbo+Palbo+Fulv group. These figures were calculated using a standard statistical method called Kaplan-Meier, which estimates timelines when not all participants have been followed for the same length of time. For all of the secondary outcomes — including the percentage of participants whose cancer shrank (objective response rate), how long those responses lasted (duration of response), overall clinical benefit, and overall survival (total length of life) — the results data was not reported on ClinicalTrials.gov at the time of this summary. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02999477 · results posted 20 September 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT02999477) involved 32 people in total, split into two groups of 16 — one group received nab-paclitaxel (a chemotherapy medicine) and the other received pembrolizumab (an immunotherapy medicine). The trial was looking at what happens before surgery for breast cancer ("neoadjuvant" treatment). It primarily measured changes in a protein marker called PD-L1, which is found on tumour cells and can be detected in tissue samples. A number of secondary measurements were also taken, including changes in immune cells within the tumour, tumour shrinkage on scans, and how many participants had no detectable cancer remaining after treatment. The reported data shows that for the primary measure — the number of participants whose PD-L1 levels scored 100 or higher (on a scale where higher means more of the marker present) — 11 out of 16 participants in the nab-paclitaxel group and 12 out of 16 in the pembrolizumab group were in this higher-score category, while none in either group scored zero. For the secondary measures, the reported data shows that immune cell activity within the tumour (called stromal tumour-infiltrating lymphocytes) changed by an average of 7.2 percentage points in the nab-paclitaxel group and 0.5 percentage points in the pembrolizumab group. When looking at tumour response on scans, 7 participants in the nab-paclitaxel group and 8 in the pembrolizumab group showed a response (including stable, partial, or complete responses). Complete clearance of cancer (no cancer found at surgery) was reported in 2 participants in the nab-paclitaxel group and 1 in the pembrolizumab group. For disease-free survival — meaning remaining free of cancer returning over the follow-up period — the reported figures were 92% for the nab-paclitaxel group and 100% for the pembrolizumab group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03280303 · results posted 20 September 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,250 people who were receiving a combination of palbociclib and endocrine (hormone-based) therapy for breast cancer. Only 54 participants were recorded as having completed the study, while 1,196 did not complete it — though in an observational study like this one, not completing does not necessarily mean dropping out due to a problem. The trial was measuring things like how tumours responded to treatment, how long it was before the disease progressed, and how long participants lived overall. It also looked at a measure of physical wellbeing (called ECOG performance status, a simple scale from 0 = fully active to 5 = deceased) in participants aged 70 and over. The reported data shows that, when looking at tumour response across different groups, roughly 30.6%, 33.7%, and 22.2% of participants (in three separate subgroups) had their tumours shrink or disappear — described as a "complete" or "partial" response. For the broader picture of tumour behaviour, the reported numbers show that 72 participants had a complete response, 310 had a partial response, 499 had stable disease (tumour neither grew significantly nor shrank), and 223 had progressive disease (tumour grew), with the remaining participants falling into other or unknown categories. The reported data also shows that the time from starting treatment until disease progression or death (called "progression-free survival") was recorded as 18.8, 21.0, and 13.2 months across different subgroups. Overall survival (time from starting treatment until death from any cause) was reported as 42.3, 48.5, and 37.2 months across those same subgroups. For participants aged 70 and over, the average ECOG physical wellbeing score was reported as 0.7 both at the start of the study and at one month — though what those subgroup breakdowns specifically represent was not further detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00626106 · results posted 19 September 2024

According to the results reported on ClinicalTrials.gov, this trial involved 156 people with breast cancer — 106 in one group and 50 in another. The main thing the trial was measuring was **progression-free survival**: how long participants went before their disease got worse, they felt significantly worse, or they died. One group received a drug called AMG 479 (also known as ganitumab) given by drip into a vein, combined with a hormone-based cancer treatment. The other group received a dummy (placebo) drip combined with the same hormone-based treatment. The reported data shows that for the primary measure — time until disease worsened or death — the AMG 479 group had a median (middle value in the group) of 3.9 months, while the placebo group had a median of 5.7 months. For some of the secondary measures: in terms of how many participants experienced adverse events (unwanted health events during the trial), 105 out of 106 people in the AMG 479 group and 47 out of 50 in the placebo group had at least one recorded. The reported data shows that 22 participants in the AMG 479 group and 10 in the placebo group experienced a measurable clinical benefit (meaning their disease either shrank or stayed stable for at least 24 weeks), while 5 and 4 participants respectively had an objective response (their disease visibly shrank). For overall survival — how long participants lived from the start of the trial — the AMG 479 group had a reported median of 96.6 weeks; the corresponding figure for the placebo group was not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03284723 · results posted 3 September 2024

According to the results reported on ClinicalTrials.gov, this trial investigated an experimental drug called PF-06804103 in people with breast cancer. A total of 95 participants took part, spread across 12 groups that received different doses of the drug (ranging from 0.15 mg/kg to 5.0 mg/kg of body weight). Some groups received the drug on its own, while one small group received it in combination with other medicines. The trial was primarily measuring how the body tolerated the drug at different dose levels — specifically looking for serious side effects early in treatment, unusual changes in blood and urine test results, and any other medical events that occurred after starting the drug. The reported data shows that, for the dose-finding phase (Part 1A), 2 out of 16 participants at the 3.0 mg/kg dose and 2 out of 15 participants at the 4.0 mg/kg dose experienced what are called "dose-limiting toxicities" (DLTs) — meaning significant side effects in the first 21 days serious enough to potentially limit how much of the drug could be given. No DLTs were recorded at the lower doses or at 5.0 mg/kg in Part 1A, and no DLTs were reported in the small combination-therapy group (Part 1B). Across all groups, every participant who started the study received at least one dose of treatment. When it came to notable changes in blood test results (such as counts of blood cells or levels of certain enzymes), the reported data shows that only 1 participant in one group showed a significant worsening in blood chemistry results, and 1 participant each in two other groups showed significant worsening in blood count results. No participants across any group showed significant worsening in urine test results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03498716 · results posted 21 August 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03498716) enrolled 2,199 people with breast cancer — 1,098 in a group receiving chemotherapy alone, and 1,101 in a group receiving chemotherapy combined with a medicine called atezolizumab (a type of immunotherapy). The trial was designed to compare these two groups across several measures, the main one being "invasive disease-free survival" — that is, how long participants went without their cancer coming back or spreading, or without dying from any cause. Secondary measures included overall survival (time from enrolment until death from any cause), recurrence-free interval, and results broken down by certain tumour characteristics such as a protein marker called PD-L1 and whether cancer had spread to nearby lymph nodes. The reported data shows that for every single outcome measure — including the primary measure of invasive disease-free survival and all secondary measures such as overall survival and recurrence-free interval — the recorded values are listed as "NA" (not available). This applies to both the chemotherapy-only group and the atezolizumab-plus-chemotherapy group. The data was not reported for any of these outcomes in the results submitted to ClinicalTrials.gov. It is also worth noting that the trial records show zero participants in either group as having "completed" the study, with all participants listed under "not completed," though the reasons for this are not detailed in the submitted data. Because no numerical outcome data has been provided in the results submitted to ClinicalTrials.gov, it is not possible to describe what the trial found about any of its measured endpoints. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03451162 · results posted 5 August 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03451162) tested an experimental drug called DHES0815A in 14 people with cancer. Participants were divided into five groups, each receiving a different dose of the drug — ranging from 0.6 milligrams per kilogram of body weight up to 6 milligrams per kilogram. The trial was primarily looking at how the drug was tolerated at each dose level, including tracking any unwanted medical events (called adverse events) and any particularly serious ones, as well as monitoring the effect on heart function. It also recorded how long participants stayed on treatment and how much of the drug they received in total. The reported data shows that across all five dose groups, every participant (all 14) experienced at least one adverse event. Serious adverse events were reported in a smaller number of people: 1 out of 3 in the lowest-dose group, 1 out of 3 in the second group, 1 out of 3 in the third group, none of the 3 in the fourth group, and 1 out of 2 in the highest-dose group. Notably, no participants in any group were recorded as experiencing a "dose-limiting toxicity" — a pre-defined level of side effect serious enough to indicate the dose is too high. Regarding heart function (measured as the percentage of blood the heart pumps out with each beat), the reported data shows small changes from starting levels across the groups, ranging from a slight increase of 0.33 percentage points in the lowest-dose group to a decrease of 5 percentage points in the highest-dose group. The longest median treatment duration reported was around 208 days in the 1.2 mg/kg group, while other groups ranged from approximately 43 to 64 days. The reported data also shows that the amount of the drug detected in participants' blood (a measure of how much the body absorbed) appeared to increase as the dose went up, with the highest-dose group showing the greatest concentration — though some early time-point figures were not reported in the data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04251533 · results posted 31 July 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04251533) enrolled 137 people across two parts. Part A included 52 people who received alpelisib plus nab-paclitaxel and 50 who received a placebo plus nab-paclitaxel — this part compared the two approaches directly. Part B1 included 35 people who all received alpelisib plus nab-paclitaxel, and was measuring how often tumours responded to this combination in a specific group of patients. The trial was looking at things like how long people went without their cancer getting worse, how often tumours shrank or disappeared, and how often people experienced any meaningful disease control over time. The reported data shows that in Part A, the main measure — how long people went without their disease getting worse (called progression-free survival) — was 7.2 months on average in the alpelisib group and 5.6 months in the placebo group. When it came to tumour shrinkage (where tumours either completely disappeared or shrank by at least 30%), this was reported in about 40% of the alpelisib group and 34% of the placebo group. A broader measure of disease control — counting anyone whose disease shrank or stayed stable for at least 24 weeks — was reported in 50% of the alpelisib group and 44% of the placebo group. For the overall survival outcome in Part A (how long people lived overall), no data was reported. In Part B1, tumour shrinkage was reported in about 14% of participants, and broader disease control for at least 24 weeks was reported in about 26% of participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03975647 · results posted 30 July 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03975647) enrolled 466 people with HER2-positive breast cancer who had previously received other treatments. Participants were randomly assigned to receive either tucatinib combined with a chemotherapy drug called ado-trastuzumab emtansine (231 people), or a placebo combined with ado-trastuzumab emtansine (235 people). The trial was primarily measuring how long people went without their cancer growing or spreading — known as progression-free survival — as well as a number of other outcomes including overall survival and how many people's tumours shrank. The reported data shows that, for the main outcome (progression-free survival as assessed by treating doctors), the tucatinib group had a median of 9.5 months before their disease progressed or they died, compared with 7.4 months in the placebo group. A separate review by an independent committee produced very similar figures: 9.6 months versus 7.4 months. For participants who already had cancer that had spread to the brain at the start of the trial, the reported median progression-free survival was 7.8 months in the tucatinib group compared with 5.7 months in the placebo group. Regarding tumour shrinkage (called objective response rate), 42.0% of participants in the tucatinib group had their tumour shrink or disappear compared with 36.1% in the placebo group. The reported data for overall survival — both across all participants and in those with brain involvement — was not included in the submitted results, so those figures cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02694640 · results posted 10 June 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT02694640) involved 161 breast cancer survivors who were split into three groups, all receiving a programme called "Reach Plus" but delivered in different ways: a standard version (55 people), a version that included phone calls (53 people), and a version that included text messages (53 people). The trial was measuring physical activity levels, as well as quality of life, fatigue, and mood. By the end of the study, 48, 43, and 35 participants respectively had completed the programme in each group. The reported data shows that, for self-reported physical activity (measured in minutes per week using a recall interview), the three groups recorded figures of around 146, 160, and 173 minutes per week at one time point, and around 121, 137, and 135 minutes per week at another. For physical activity measured using a wearable device (an accelerometer), the reported figures were approximately 46, 82, and 55 minutes per week at one time point, and around 62, 69, and 50 minutes per week at another. On the quality-of-life scale (scored 0–148, where higher means better), all three groups scored in the mid-20s at both time points. On the fatigue scale (scored 0–52, where higher means less fatigue), scores across all groups were in the low-to-mid 40s. On the mood disturbance scale (scored 0–28, where higher means more disturbance), scores ranged roughly from 5 to 9 across the groups and time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03205761 · results posted 1 May 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03205761) enrolled 11 participants, all of whom received the drug olaparib. The trial was a single-group study — meaning there was no comparison group — and it was measuring how tumours responded to the treatment using a standard set of criteria called RECIST, which judges response based on changes in the size of tumours on scans. None of the 11 participants were recorded as having completed the study; all 11 were listed under "not completed." The reported data shows that out of the participants assessed for tumour response, 1 person showed a measurable tumour response (either tumours disappearing entirely or shrinking by at least 30%). A further 4 participants met the definition of "clinical benefit," meaning they either had a tumour response or their disease remained stable for at least 24 weeks. For the 1 person whose tumour did respond, the reported duration of that response was 18.4 months. The reported data also shows that the median time before disease progressed or death occurred across the group was 1.8 months, and the median overall survival — the time from joining the study until death from any cause — was 8.9 months. Separately, 8 out of 11 participants were reported as having experienced at least one side effect considered related to the study treatment, though the specific nature or severity of those side effects is not broken down further in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04243837 · results posted 23 April 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04243837) looked at a medicine called LYT-100 in people with breast cancer-related lymphoedema (BCRL) — a condition where fluid builds up and causes swelling, usually in the arm, after breast cancer treatment. A total of 50 people took part: 28 were given LYT-100 and 22 were given a placebo (a dummy treatment with no active ingredient). Of those who started, 10 people in the LYT-100 group and 7 in the placebo group completed the study, meaning a notable number of participants in both groups did not finish. The reported data shows that the primary (main) outcome the trial was measuring was safety and tolerability — specifically, how many participants experienced what are called "treatment-emergent adverse events" (TEAEs), which simply means any unwanted health events that occurred after starting the treatment. According to the results reported on ClinicalTrials.gov, 22 out of 28 participants (roughly 79%) in the LYT-100 group experienced at least one such event, compared with 13 out of 22 participants (roughly 59%) in the placebo group. No other outcome measure results were included in the structured data submitted, so additional findings were not reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03337724 · results posted 12 March 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 579 people across five groups. Participants had breast cancer and were divided based on certain tumour characteristics (Cohort A, B, or C). Cohorts A and B compared a drug called ipatasertib combined with paclitaxel (a chemotherapy) against a placebo combined with paclitaxel. Cohort C tested ipatasertib alongside two other drugs — paclitaxel and atezolizumab — without a comparison group. The main thing being measured was how long participants went before their cancer grew or spread further, known as "progression-free survival." The reported data shows that in Cohort A, the median time before cancer progressed was 6.1 months in the placebo group and 7.4 months in the ipatasertib group (median meaning half the participants reached that point sooner, half later). In Cohort B, both the placebo and ipatasertib groups had a median progression-free survival of 9.3 months. In Cohort C, the single group had a median of 7.1 months. For secondary outcomes, the trial also measured how many participants had their tumours shrink (called the "objective response rate"). The reported figures were: Cohort A placebo 34.9%, Cohort A ipatasertib 38.9%; Cohort B placebo 46.7%, Cohort B ipatasertib 46.5%; and Cohort C 52.9%. The trial also tracked how long those responses lasted — in Cohort A, the placebo group's response lasted a median of 16.6 months versus 9.4 months in the ipatasertib group; in Cohort B, both groups were 9.2 months. It is worth noting that no participants were recorded as having "completed" the trial in the formal sense, as all participants fell into the "not completed" category — this likely reflects how oncology trials are structured, but the reasons were not detailed in the submitted data. The reported data does not include information on side effects or safety outcomes within these structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03321981 · results posted 7 March 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03321981) enrolled 104 participants in total, split across three groups: 15 people in "Cohort 1 Doublet," 39 people in "Cohort 1 Triplet," and 50 people in "Cohort 2." The trial was measuring how many participants showed a meaningful response to treatment — either their cancer shrinking or staying stable — over a period of 24 weeks. It also tracked how long it took for the cancer to start growing again or for a participant to die from any cause (called progression-free survival), as well as how many participants had their cancer shrink and for how long that shrinkage lasted. Notably, the data shows that none of the participants were recorded as having "completed" the study in the conventional sense, as all participants were listed under "not completed." The reported data shows that for the main measure — the number of participants with a clinical benefit (cancer shrinking or staying stable) at 24 weeks — the figures were 3 out of 15 in the Doublet group, 18 out of 39 in the Triplet group, and 9 out of 50 in Cohort 2. For the number of participants whose cancer was recorded as shrinking (either fully or partially), the Doublet group reported 0, the Triplet group reported 10 (by the treating doctors' assessment) or 6 (by an independent central review), and Cohort 2 reported 1 (by doctors) or 0 (by central review). The reported data shows the median time until the cancer grew or a participant died was approximately 1.4 months for the Doublet group, 5.5 months for the Triplet group, and 2.6 months for Cohort 2, based on doctors' assessments. For participants whose cancer did shrink, the reported data shows the length of time that shrinkage lasted was a median of approximately 4.2 months in the Triplet group and 4.5 months in Cohort 2, as assessed by treating doctors. No duration of response figure was reported for the Doublet group, as no participants in that group had a recorded tumour response. No duration of response data was reported from the independent central review. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02752685 · results posted 6 March 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 70 people with breast cancer across three groups: 20 with hormone receptor-positive (HR-positive) breast cancer, 30 with a type called confirmed triple-negative breast cancer (cTNBC), and 20 with another type called inflammatory triple-negative breast cancer (iTNBC). Nearly all participants completed the study — 19, 29, and 19 people respectively, with one person in each group not completing. The trial was primarily measuring how many participants had their tumours shrink or disappear entirely in response to treatment. The reported data shows that, looking at the best overall response — meaning the best result each person achieved during the trial — 5 out of 20 participants in the HR-positive group, 9 out of 30 in the cTNBC group, and 10 out of 20 in the iTNBC group had a complete response (tumour fully disappeared on scans) or partial response (tumour shrank by at least 30%). These are the raw counts as submitted to ClinicalTrials.gov. For the secondary outcomes — including how long it took for the disease to worsen (progression-free survival), how long participants lived overall (overall survival), how many people's disease shrank or stayed stable (disease control rate), and how long responses lasted (duration of response) — the data was not reported in the structured results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05155566 · results posted 26 January 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT05155566) enrolled 847 people in total — 574 in a group receiving palbociclib combined with a type of hormone-blocking medicine called an aromatase inhibitor, and 273 in a group receiving palbociclib combined with a different hormone-blocking medicine called fulvestrant. The trial was set up to track how many participants showed no signs of their cancer getting worse over time (called being "progression free"), as well as how many showed a measurable reduction in visible disease, and how many were still alive after one year. The reported data shows the following progression-free figures — meaning the estimated percentage of people whose disease had not worsened by each point in time. In the aromatase inhibitor group: roughly 93% at 6 months, 81% at 12 months, 69% at 18 months, and 61% at 24 months. In the fulvestrant group: roughly 91% at 6 months, 76% at 12 months, 66% at 18 months, and 56% at 24 months. These percentages are estimates produced using a standard statistical method (called Kaplan-Meier analysis) that accounts for participants who left the study before each time point. The reported data also shows that approximately 70% of participants in the aromatase inhibitor group and 67% in the fulvestrant group had a recorded reduction in their visible disease during treatment (either a complete or partial reduction). Regarding survival at one year, around 95% of the aromatase inhibitor group and approximately 97% of the fulvestrant group were reported to be alive at that point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02834403 · results posted 15 December 2023

According to the results reported on ClinicalTrials.gov, this trial enrolled 37 people in total across two phases. The first part (Phase Ib) involved 15 participants spread across six groups, each receiving different dose combinations of an experimental drug called L-NMMA alongside a chemotherapy drug called docetaxel. The goal of this first phase was to find the highest dose of L-NMMA that could be given without causing too many serious side effects — this is known as the "maximum tolerated dose." The second part (Phase II) enrolled 22 participants at the dose level identified in Phase Ib, and measured how many people experienced a complete response (all signs of cancer disappearing), a partial response (tumours shrinking by 30% or more), or stable disease (no significant change) after six treatment cycles. All participants had a type of breast cancer known as triple-negative breast cancer (TNBC) that had not responded to previous treatments. The reported data shows that in Phase Ib, the highest dose tested — 20 mg/kg of L-NMMA combined with docetaxel — was identified as both the maximum tolerated dose and the recommended dose to carry forward into Phase II. Regarding serious side effects (defined as Grade 3 or higher, meaning severe or worse), the reported numbers were: 0 events in the 7.5, 10, 12.5, and 15 mg/kg groups; 2 events in the 17.5 mg/kg group; and 1 event in the 20 mg/kg group. In the Phase II portion, out of 20 evaluable participants, the reported clinical benefit results were: 0 complete responses, 2 partial responses, 3 stable disease outcomes, and 6 classified as progressive disease (cancer worsening); 2 were recorded as treatment failures, and the remaining figures across other categories were also reported but some sub-category breakdowns in the data are not fully labelled. For the drug concentration timing measure, the reported time to peak blood levels was 2 hours for L-NMMA and 4 hours for docetaxel in the dose groups where this was measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01864746 · results posted 12 December 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT01864746) enrolled around 1,250 people with a specific type of breast cancer — hormone receptor-positive, HER2-normal — who had already received chemotherapy before surgery and were considered at higher risk of the cancer returning. Participants were randomly assigned to receive either palbociclib (631 people) or a placebo (619 people), alongside standard hormone-blocking therapy. The trial was primarily measuring how many people remained free of invasive disease (meaning no return or spread of breast cancer, no new cancer, and no death) over the follow-up period. The reported data shows two sets of figures for each outcome, which appear to reflect results at two different points in time during the follow-up. For the primary measure — invasive disease-free survival — 81.2% of the palbociclib group and 77.7% of the placebo group were free of such events at the earlier time point, while at the later time point the figures were 63.6% for palbociclib and 67.9% for placebo. For overall survival (the proportion of participants still alive), the reported figures were 93.6% (palbociclib) versus 90.5% (placebo) at the earlier point, and 79.6% versus 84.6% at the later point. Similar patterns of two time-point figures were also reported for the other secondary measures, including distant disease-free survival and invasive disease-free survival excluding second non-breast cancers. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00618657 · results posted 4 October 2023

According to the results reported on ClinicalTrials.gov, this trial enrolled 127 people with breast cancer across two groups: 42 participants whose cancer tested positive for a protein called HER-2 (Arm I), and 85 participants whose cancer tested negative for that protein (Arm II). All 127 participants who started the trial also completed it. The trial was measuring how long people went without their cancer getting worse (called progression-free survival), as well as how the cancer responded to treatment before surgery and what side effects were recorded. The reported data shows that for the primary measure — progression-free survival, meaning the percentage of participants whose cancer had not progressed — 95% of participants in the HER-2 positive group and 93% in the HER-2 negative group were reported at the measured time point. For one of the secondary measures, looking at participants who had no detectable cancer remaining in the surgical tissue after pre-surgery treatment (known as a pathological complete response, or pCR), 21 out of 42 participants were reported in the HER-2 positive group and 15 out of 85 in the HER-2 negative group. Regarding side effects, 19 out of 42 participants in the HER-2 positive group and 50 out of 85 in the HER-2 negative group were reported as experiencing toxicities (unwanted physical reactions). The reported data shows no numbers were submitted for the clinical complete response measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04478266 · results posted 6 July 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04478266) enrolled 1,068 people in total — 534 in each group. One group received a combination of letrozole and palbociclib, and the other received a combination of amcenestrant and palbociclib. The trial was primarily measuring how long participants went without their cancer growing or spreading — a measure called "progression-free survival" — and also looked at a range of other outcomes including overall survival, how many participants showed a measurable reduction in tumour size, how long that reduction lasted, and how many experienced a broader "clinical benefit" (meaning their disease either shrank or stayed stable for at least 24 weeks). The reported data shows that the median time without disease progression was 16.6 months in the letrozole + palbociclib group and 14.1 months in the amcenestrant + palbociclib group. (Median means half the participants in each group reached that point before or after that time.) At the 12-month mark, approximately 68.2% of participants in the letrozole + palbociclib group and 65.5% in the amcenestrant + palbociclib group had not yet experienced disease progression. A measurable tumour response was recorded in 42.3% of participants in the letrozole + palbociclib group and 32.2% in the amcenestrant + palbociclib group. The reported data shows that how long those responses lasted (duration of response) was a median of 14.0 months in the letrozole + palbociclib group; this figure was not reported for the amcenestrant + palbociclib group. Clinical benefit was reported in 82.4% of the letrozole + palbociclib group and 76.0% of the amcenestrant + palbociclib group. Overall survival data was not reported for either group at the time of this data submission. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03734029 · results posted 15 June 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT03734029) enrolled 557 people with HER2-low breast cancer — 373 received a medicine called Trastuzumab Deruxtecan (also known as T-DXd), and 184 received what is called "Physician's Choice" treatment (meaning their doctor selected from standard available options). The trial was primarily measuring how long participants went without their cancer growing or spreading — a timeframe known as "progression-free survival." The reported data shows that, in the main group of interest (those whose breast cancer was also hormone receptor-positive), the middle value — called the median — for time without disease progression was 10.1 months for the T-DXd group, compared with 5.4 months for the Physician's Choice group. When looking at all participants in the trial regardless of hormone receptor status, the reported median figures were 9.9 months for T-DXd and 5.1 months for Physician's Choice. For overall survival — meaning how long participants lived from the start of the trial — the reported median in the hormone receptor-positive group was 23.9 months for T-DXd and 17.5 months for Physician's Choice. During the study, 149 deaths were recorded in the T-DXd group and 90 in the Physician's Choice group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02955394 · results posted 15 June 2023

According to the results reported on ClinicalTrials.gov, this trial enrolled 61 people in total — 27 in a group receiving fulvestrant alone, and 34 in a group receiving fulvestrant combined with enzalutamide. The trial was looking at a scoring system called the PEPI score, which combines several tumour measurements taken at the time of surgery to give an indication of how much a cancer may have responded to hormone-based treatment before surgery. A PEPI score of zero is considered the best possible result on this scale. The reported data shows that, of the participants assessed, 2 out of 27 people in the fulvestrant-alone group had a PEPI score of zero after treatment, compared with 8 out of 34 people in the combined treatment group. For a secondary measure called disease-free survival — meaning the time from the start of treatment until the cancer was recorded as progressing or the person passed away — the reported figures were 3.6 months for the fulvestrant-alone group and 3.7 months for the combined group. The reported data also shows that a measure of androgen receptor activity (looking at what percentage of certain related genes were "switched on") was 85% in the fulvestrant-alone group and 80% in the combined group. One secondary outcome — examining how the PEPI score related to other results across all participants — was listed in the trial but no figures were reported for it. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02636582 · results posted 16 May 2023

According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 13 participants across two groups: 4 people received GM-CSF alone (the control group) and 9 people received Nelipepimut-S combined with GM-CSF (the experimental group). The trial was looking at whether a vaccine-like treatment called Nelipepimut-S, given before surgery for a type of breast condition called ductal carcinoma in situ (DCIS), could change the levels of certain immune cells in the body and within the tumour tissue. Twelve of the 13 participants completed the study; one person in the control group did not complete it. The reported data shows that the primary outcome — a measure of a specific type of immune cell response (cytotoxic T lymphocytes targeted at the Nelipepimut-S protein) — changed by an average of 0.09% in the control group and 0.02% in the Nelipepimut-S group from the start of the study to one month after surgery. For the secondary outcomes, the reported data shows that immune cells measured within the tumour tissue (called tumour-infiltrating lymphocytes) showed a change of 0% in the control group and 0.5% in the Nelipepimut-S group for one measure, and 0% in both groups for a second related measure. Regarding unwanted events (adverse events), the control group had 0 serious and 40 non-serious events recorded, while the Nelipepimut-S group had 2 serious and 91 non-serious events recorded. Some additional measurements about tumour characteristics (HER2 expression and presence of DCIS) were also reported, though the breakdown across multiple sub-categories makes those figures difficult to summarise simply without further context. It is worth noting that this was a very small trial with only 13 participants, which means the reported numbers reflect a limited group of people. The reported data shows what was measured in this specific study — it does not on its own tell us what these results mean more broadly. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00634634 · results posted 6 May 2023

According to the results reported on ClinicalTrials.gov, this trial involved 52 people in total. It was conducted in two stages. The first stage (Phase I) tested different doses of a drug called sorafenib combined with a fixed dose of another drug called letrozole, to find the highest dose of sorafenib that participants could tolerate without unacceptable side effects — this is known as the "maximum tolerated dose" or MTD. Thirteen people took part in this dose-finding stage, spread across three dose levels. The second stage (Phase II) then enrolled 39 people at the dose identified in Phase I. All 52 participants completed the study as enrolled, with none recorded as having dropped out in the reported data. The reported data shows that the maximum tolerated dose of sorafenib, when combined with 2.5 mg of letrozole daily, was identified as 400 mg taken twice a day. For the secondary outcomes, the trial measured the "clinical benefit rate" — meaning the number of participants whose disease either did not get worse or showed some reduction. The reported figures were: 0 out of 1 participant at the lowest dose level, 3 out of 3 at the next level, 4 out of 9 at the highest Phase I dose level, and 23 out of 39 in the main Phase II group. The reported data also shows figures for how long participants went without their disease progressing (progression-free survival): 0 months, 10 months, 34.5 months, and 11 months across the four groups respectively. For overall survival — meaning how long participants were alive from the start of treatment — the reported mean (average) figures were 44 months, 21 months, 49.6 months, and 24.8 months across the four groups. It is worth noting that the Phase I groups were very small (as few as 1 person), so those individual figures should be interpreted with caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02142959 · results posted 6 May 2023

According to the results reported on ClinicalTrials.gov, this trial looked at a topical lotion called omaveloxolone (also known as RTA 408) applied to the skin during breast radiation therapy. The trial was testing whether the lotion could affect radiation dermatitis — a skin reaction (like redness, peeling, or raw patches) that can occur when people have radiation treatment to the breast. A total of 187 people took part across three groups: 64 received the 0.5% strength lotion, 62 received the 3% strength lotion, and 61 received a vehicle lotion (a lotion with no active ingredient, used for comparison). The majority of participants in each group completed the study. The reported data shows that the main thing being measured was the average grade of skin reaction experienced over the course of treatment, using a standard 0–5 grading scale (where 0 means no skin reaction and higher numbers mean more severe reactions). According to the results reported on ClinicalTrials.gov, the average grade score was 1.1 for the group using the 0.5% lotion, 1.2 for the group using the 3% lotion, and 1.2 for the group using the vehicle lotion (the no-active-ingredient comparison). A grade around 1 on this scale corresponds to mild reactions such as faint redness or dry, flaking skin. The reported data shows very similar average scores across all three groups. No secondary outcome measure data was included in the structured results provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03321929 · results posted 1 May 2023

According to the results reported on ClinicalTrials.gov, this trial enrolled 234 participants, all of whom used the LUM Imaging System (also called the Lumicell Imaging System) during breast lump removal surgery (lumpectomy). Four participants did not complete the study, leaving 230 who finished. The trial was primarily collecting data to refine and test a computer-based tool designed to detect whether any cancer tissue had been left behind after the surgeon completed their standard lumpectomy procedure. The reported data shows that, across all participants, 11.3% had residual cancer tissue (cancer left in the surgical cavity after the standard procedure) that was then identified and removed using guidance from the LUM Imaging System. When looking only at participants whose standard surgical margins were already flagged as positive (meaning the surgeon had already identified a concern about incomplete removal), the reported rate of additional residual cancer found with LUM guidance was 31.6%. For participants whose standard surgical margins appeared clear (negative), the reported rate was 7.3%. The reported data also shows figures described as "sensitivity" and "specificity" — in plain terms, these measure how often the imaging system correctly flagged areas with cancer (69.3%) and how often it correctly identified areas without cancer (71.7%), assessed at the level of individual tissue samples. Regarding adverse events (unwanted medical occurrences tracked during the study), the reported numbers varied across different event categories; notably, 214 participants had at least one adverse event recorded of some kind, though the data as submitted does not provide a full breakdown of categories in a way that allows plain description of each figure without risk of misrepresentation. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04436744 · results posted 2 February 2023

According to the results reported on ClinicalTrials.gov, this trial enrolled 221 people in total — 112 in the giredestrant plus palbociclib group and 109 in the anastrozole plus palbociclib group. The trial was looking at treatments for a type of breast cancer, and its main focus was measuring changes in a protein called Ki67, which is a marker found in tumour cells that indicates how quickly those cells are dividing. A lower Ki67 reading after two weeks of treatment was considered a more favourable change. The trial also tracked a number of secondary measures, including how many participants' tumours shrank, how many participants reached a specific threshold of tumour cell activity slowdown, and various physical observations such as pulse and breathing rates. The reported data shows that the main outcome — the relative change in Ki67 scores after two weeks — was a 25% change in the giredestrant plus palbociclib group and a 33% change in the anastrozole plus palbociclib group (where a smaller number represented a more favourable result). For the secondary outcomes, the reported data shows that around 50% of participants in both groups had their tumours shrink to a measurable degree as assessed by ultrasound (50.0% in the giredestrant group and 49.1% in the anastrozole group). Approximately 19.6% of participants in the giredestrant group and 12.8% in the anastrozole group reached a specific low level of tumour cell activity (Ki67 at or below 2.7%) at the two-week mark. The reported data also shows that changes in breathing rate and pulse rate over the course of the study were small in both groups, though the full breakdown of those figures across all time points was not reported in a way that allows straightforward plain-English summary of every data point. Regarding unwanted medical events (called adverse events) that participants experienced during the trial, the reported data shows that 104 out of 112 participants in the giredestrant group and 98 out of 109 in the anastrozole group experienced at least one such event of any severity. Events recorded as severe or requiring hospitalisation (Grade 3) were reported in 45 participants in each group, and life-threatening events (Grade 4) were reported in 4 participants in the giredestrant group and 2 in the anastrozole group. One participant death related to an adverse event was recorded in the giredestrant group, and none in the anastrozole group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03344536 · results posted 25 November 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT03344536) enrolled 10 participants, all in Cohort 1, which tested a combination of two medicines — fulvestrant and Debio 1347. A second group (Cohort 2, described as an expansion group) was listed but had zero participants. The trial was measuring two main things: how many participants experienced a "dose limiting toxicity" (meaning a side effect serious enough that it would affect how much of the medicine could be given), and how many participants had the best overall response to treatment (meaning how their tumours responded, assessed using a standard set of imaging rules called RECIST v1.1). The reported data shows that, out of the 10 participants, zero experienced a dose limiting toxicity. For the tumour response measure, the reported data shows that 2 out of 10 participants had a recorded best overall response, while 8 out of 10 did not. No further breakdown of what type of response was observed (for example, whether tumours shrank, stayed the same, or grew) was included in the data submitted to ClinicalTrials.gov. It should also be noted that Cohort 2 reported no data, as no participants were enrolled in that group. It is worth noting that this was a very small group of 10 people, and the reported numbers reflect only what was observed in this specific trial setting. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02124902 · results posted 7 November 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 148 participants across two sites — 123 at Washington University and 25 at Baylor. The trial was looking at a treatment combination given before surgery (called "neoadjuvant" treatment) consisting of two chemotherapy medicines, docetaxel and carboplatin, for breast cancer patients. Of those who started the trial, 106 participants at Washington University and 19 at Baylor completed it, meaning 17 and 6 participants respectively did not finish. The main thing the trial was measuring was something called a "pathological complete response" (pCR) rate. In plain terms, this means that after completing the pre-surgery treatment, when surgeons removed tissue and examined it under a microscope, there were no detectable invasive cancer cells left in the breast tissue or the lymph nodes under the arm. The reported data shows that out of 123 participants at Washington University, 47 had this outcome, and out of 25 participants at Baylor, 11 had this outcome. No other outcome measures were included in the data reported to ClinicalTrials.gov. It is worth noting that the reported data does not include any additional secondary outcome measures, so further detail beyond the figures above was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04109391 · results posted 26 October 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT04109391) enrolled 338 people across three groups: 175 received TX05 only (a biosimilar medicine — a close copy of an existing approved medicine), 82 received Herceptin only (the original reference medicine), and 81 switched from Herceptin to TX05 partway through. The trial was measuring three things: whether the body developed immune reactions to the medicines (called anti-drug antibodies), how long participants remained free of breast cancer returning or a new cancer appearing (disease-free survival), and whether participants were still alive at the end of the follow-up period (overall survival). The reported data shows that very few participants developed detectable immune reactions to the medicines. In the TX05-only group, 3 out of 175 participants tested positive for anti-drug antibodies; in the Herceptin-only group, 2 out of 82 did; and in the switching group, 3 out of 81 did. Notably, none of these participants went on to test positive for neutralising antibodies (a stronger type of immune reaction that can block a medicine from working). The reported data shows that the majority of participants in all three groups were assessed as not having experienced a first cancer event during the study period — 160, 73, and 76 participants respectively in each group. For overall survival, no deaths were recorded in the TX05-only or Herceptin-only groups; one death was recorded in the switching group. It is worth noting that some figures within the data, such as the precise breakdown of all immune reaction categories across all timepoints, were not fully separated out in the submitted results, so a complete picture cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00530868 · results posted 21 October 2022

According to the results reported on ClinicalTrials.gov, this trial involved 75 people in total — 50 in a group receiving a combination of letrozole and bevacizumab (also known as Avastin), and 25 in a group receiving letrozole alone. All 75 participants completed the study. The trial was measuring how tumours responded to these treatments before surgery, looking at two things: whether the cancer had completely disappeared from breast tissue and nearby lymph nodes by the time of surgery (called a "pathologic complete response"), and how the tumour appeared on scans such as ultrasound or MRI during treatment. The reported data shows that, for the main measurement — complete disappearance of the tumour in surgical tissue — 11% of participants in the letrozole-plus-Avastin group achieved this result, compared with 0% in the letrozole-alone group. For the secondary measurement — how tumours appeared on scans — the reported data shows that 10 participants in the combination group and 4 participants in the letrozole-alone group showed a complete response on imaging. No other secondary outcome numbers were reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03659136 · results posted 29 September 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT03659136) enrolled 103 people with cancer — 52 in the group receiving a combination of xentuzumab, everolimus, and exemestane, and 51 in the group receiving a placebo alongside everolimus and exemestane. The trial was primarily measuring **progression-free survival** — that is, how long participants went without their disease getting worse or dying. It also tracked several secondary measures, including overall survival, how many participants had their disease stabilise or respond to treatment, and how long that lasted, as well as changes in pain over time. The reported data shows that, for the primary measure, participants in the xentuzumab combination group went a median (the midpoint value across the group) of 12.7 months before their disease progressed or they died, compared with 11.0 months in the placebo combination group. For overall survival — how long participants lived overall — the data was reported as "not available" for both groups, meaning those figures were not provided in the submitted results. Regarding disease control (meaning the disease at least stabilised), 29 out of 52 participants in the xentuzumab group and 25 out of 51 in the placebo group met that measure. Among those who achieved disease control, the reported duration was 14.6 months in the xentuzumab group and 18.4 months in the placebo group. Six participants in the xentuzumab group and five in the placebo group had a measurable shrinkage in their tumour. For time until pain worsened, the reported figures were 5.6 months in the xentuzumab group and 3.0 months in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03789110 · results posted 27 September 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled 30 participants, all of whom received a combination of two medicines called nivolumab and ipilimumab. None of the 30 participants were recorded as having "completed" the study — all 30 were listed under "not completed," though the data does not explain the reasons for this. The trial was primarily measuring how many participants showed a meaningful shrinkage of their tumours, using a standard set of measuring rules called RECIST 1.1. The reported data shows that, out of the 30 participants, 5 showed a complete or partial tumour response according to the standard RECIST 1.1 criteria. When a different set of measuring rules (called immune-related response criteria, or irRC) was used instead, 6 participants showed a response. For "clinical benefit" — meaning tumour shrinkage or stable disease lasting at least 24 weeks — the reported data shows this was recorded for 5 participants. The reported median time before the disease progressed or death occurred (called progression-free survival) was 1.4 months, meaning half of participants reached that point before 1.4 months and half after. The reported median overall survival — the midpoint for how long participants lived from the time they joined the study — was 19.3 months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04075604 · results posted 10 August 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT04075604) enrolled 23 people across three groups, testing different doses of a combination treatment (involving the drugs nivolumab and palbociclib) given before surgery for breast cancer. The groups were: Cohort 1 at Dose Level 1 (2 participants), Cohort 2 at Dose Level 1 (9 participants), and Cohort 2 at Dose Level 2 (12 participants). The trial had a two-part design — a safety testing phase followed by a planned randomised phase — but the reported data notes that the trial was closed after the safety phase, so the randomised phase never took place. The reported data shows that during the safety phase, the number of participants who experienced a "dose-limiting toxicity" (a side effect serious enough within the first treatment cycle to potentially limit the dose) was zero in Cohort 1 and zero in Cohort 2 at Dose Level 2, while 2 out of 9 participants in Cohort 2 at Dose Level 1 met this definition. Because the trial did not proceed to the randomised phase, no results were reported for the main planned outcome measure (how many participants had little or no cancer remaining after treatment). For the secondary measures, the proportion of participants whose tumours shrank significantly on scans was reported as 0% in Cohort 1, approximately 67% in Cohort 2 at Dose Level 1, and 75% in Cohort 2 at Dose Level 2. The proportion who had no detectable invasive cancer remaining at surgery (called a pathological complete response) was 0% in both Cohort 1 and Cohort 2 at Dose Level 1, and approximately 8% in Cohort 2 at Dose Level 2. Breast-conserving surgery rates were reported at 50%, 56%, and 50% across the three groups respectively. The reported data also shows that all participants in every group — 2, 9, and 12 respectively — experienced at least one adverse event (an unwanted medical occurrence during the study). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02400476 · results posted 6 May 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT02400476) enrolled a total of 563 people with early-stage HER2-positive breast cancer who had previously been treated with a medicine called trastuzumab. Participants were divided into six groups, each receiving the cancer drug neratinib alongside a different approach to managing diarrhoea — including loperamide alone, loperamide combined with budesonide, loperamide combined with colestipol, colestipol with loperamide used only when needed, or one of two different gradual dose-increase schedules for neratinib. The trial's main focus was measuring how many people in each group experienced severe diarrhoea (defined as 7 or more extra bowel movements per day above their normal pattern, or needing hospitalisation). The reported data shows that, for the primary measure of severe diarrhoea (Grade 3 or higher), the percentages across the six groups were: 30.7% in the loperamide-only group, 28.1% in the budesonide-plus-loperamide group, 20.6% in the colestipol-plus-loperamide group, 32.7% in the colestipol-with-loperamide-as-needed group, 13.3% in the first dose-escalation group, and 27.4% in the second dose-escalation group. For milder levels of diarrhoea, the reported data shows that Grade 1 (fewer than 4 extra bowel movements per day) ranged from roughly 23% to 40% across groups, and Grade 2 (4–6 extra bowel movements per day) ranged from roughly 25% to 45% across groups. The reported data also shows that serious adverse events — that is, unexpected medical events considered significant enough to report formally — occurred in between approximately 2.9% and 8.3% of participants depending on the group. A broader category of pre-selected events of interest (covering effects on the gut, liver, lungs, heart, and skin) was reported in between approximately 82% and 98% of participants across the groups, though the data does not break these down further by body system in the figures provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03529110 · results posted 29 April 2022

According to the results reported on ClinicalTrials.gov, this trial (known as DESTINY-Breast03) enrolled 524 people with a type of breast cancer that had spread or could not be surgically removed (called HER2-positive metastatic breast cancer) and who had previously received certain standard treatments. Participants were divided into two groups: 261 people received a medicine called trastuzumab deruxtecan (T-DXd), and 263 received a medicine called ado-trastuzumab emtansine (T-DM1). The trial was primarily measuring "progression-free survival" — that is, how long participants went without their cancer growing or spreading, or without dying. The reported data shows that for the primary measure of progression-free survival (assessed by an independent review team), a final median number was not reported for the T-DXd group, while the T-DM1 group had a median of 6.8 months. (A "median" here means the point at which half the participants in that group had experienced disease progression or death, and half had not yet.) When the treating doctors made their own assessments of progression-free survival, the reported median was 25.1 months for the T-DXd group and 7.2 months for the T-DM1 group. For the percentage of participants whose tumours shrank to a meaningful degree (called the objective response rate), the reported figures were approximately 79.7% (T-DXd) versus 34.2% (T-DM1) by the independent review team, and 77.0% (T-DXd) versus 36.9% (T-DM1) by the treating doctors. The reported data shows that median overall survival — how long participants lived overall — was not reported for either group at the time the results were submitted. Similarly, the median duration of response (how long tumour shrinkage lasted) was not reported for either group in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01724866 · results posted 15 April 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled 148 people in total, spread across four groups. Three groups received different doses of an investigational medicine called SPI-2012 (45, 135, or 270 micrograms per kilogram of body weight) alongside a chemotherapy combination known as TC (docetaxel and cyclophosphamide). The fourth group received an already-approved medicine called pegfilgrastim alongside the same chemotherapy. Both SPI-2012 and pegfilgrastim belong to a class of medicines designed to support white blood cell levels during chemotherapy. The trial was primarily measuring how long participants experienced a severe dip in a type of white blood cell (called neutrophils) during the first round of chemotherapy — a period known as severe neutropenia. The reported data shows that, in the first chemotherapy cycle (the primary measure), the average duration of severe neutropenia was 1.03 days in the lowest-dose SPI-2012 group, 0.44 days in the middle-dose group, 0.03 days in the highest-dose group, and 0.31 days in the pegfilgrastim group. For the secondary measures tracking the same thing across later chemotherapy cycles (cycles 2, 3, and 4), the reported figures were generally low across all groups, ranging from 0.03 to 1.05 days. The trial also tracked how many days it took for white blood cell counts to recover after chemotherapy. The reported data shows recovery times in cycle 1 ranged from 8.0 days (highest SPI-2012 dose) to 10.0 days (lowest SPI-2012 dose), with the pegfilgrastim group at 9.0 days. In cycle 2, recovery times ranged from 9.5 to 11.0 days across the groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02269670 · results posted 5 April 2022

According to the results reported on ClinicalTrials.gov, this clinical trial was testing a combination of two medicines — everolimus and hormone therapy — in a single group of participants. The trial intended to measure how well the treatment controlled cancer (looking at tumour response rates and how long people went without their disease getting worse), as well as overall survival and any unwanted side effects. However, the reported data shows that only 3 people were enrolled in the study, none of them completed it, and all 3 did not finish — most likely because the trial was stopped early. The reported data shows that the study was terminated ahead of schedule due to difficulties recruiting enough participants. As a result, none of the planned outcome measures — including tumour response rate, progression-free survival (how long a person lives without the disease worsening), overall survival, or side effect rates — were ever assessed or reported. There are simply no numbers available for any of these measures. Because the trial closed before it could properly run, no conclusions can be drawn from it about the treatment being studied. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03084536 · results posted 31 March 2022

According to the results reported on ClinicalTrials.gov, this trial looked at whether a type of nerve block called a PECS block (an injection given before surgery to numb nerves in the chest wall) could reduce pain and improve quality of life compared to a placebo (dummy) injection. A total of 134 people were enrolled — 53 received the real PECS block before their operation, 54 received the placebo block, and 27 others participated but were not randomly assigned to either group. The main things the trial set out to measure were pain levels and how much pain interfered with daily life, all assessed one year after surgery using a standard questionnaire where 0 means no pain and 10 means the worst imaginable pain. The reported data shows that at the one-year mark, both groups — those who received the real PECS block and those who received the placebo — scored 0 out of 10 on all three primary pain measures: worst pain in the past week, average pain, and how much pain interfered with everyday activities such as sleep, mood, and work. For the secondary measures looking at quality of life, the reported data shows changes from the start of the trial to follow-up. For physical health, the PECS block group showed a change of −3.1 points and the placebo group showed a change of −0.8 points (where a lower number means a decline in physical health score). For mental health, the PECS block group showed a change of 0 points and the placebo group showed a change of +1.9 points. The scale used has an average of 50, with higher scores indicating better quality of life. It is worth noting that the primary pain outcome scores of 0 for both groups at one year may reflect the characteristics of participants who completed follow-up, though no further explanation was provided in the submitted data. No additional breakdown or explanatory notes about these figures were reported on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02720185 · results posted 25 February 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled 5 people, all of whom received a daily 100 mg dose of a drug called dasatinib. Four of the five participants completed the study, and one did not. The trial was looking at a specific type of breast cancer called triple negative breast cancer (TNBC), and its main goal was to measure whether dasatinib changed the level of a particular protein — called EGFR — on the surface of cancer cells. The researchers set a threshold of at least a 25% increase in that protein level as their marker of interest. The reported data shows that the two measurements recorded for the primary outcome — surface EGFR levels — were 0.54% and 0.40%, both well below the 25% increase the researchers had defined as significant. For the secondary outcomes, the trial tracked unwanted side effects that were considered possibly, probably, or definitely related to the study drug over up to 4 weeks; the reported data shows 10 such events were recorded, with individual counts of 4, 2, and eight separate events each counted as 1. Regarding cancer response, the reported data shows that 1 out of the 5 participants had a pathologic complete response — meaning no detectable cancer was found in breast tissue or lymph nodes at surgery. For longer-term follow-up, the reported data shows 1 participant had no evidence of disease, while 4 participants had a different follow-up outcome, though the data does not specify further detail on what that outcome was. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03556358 · results posted 14 January 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT03556358) enrolled 809 people in total — 404 assigned to a medicine called TX05 (a version of trastuzumab) and 405 assigned to the already-approved medicine Herceptin®. The trial was designed for people with a certain type of breast cancer, and it was measuring whether the two medicines produced similar results before surgery. The main thing being measured was something called a pathologic complete response — this means that when surgeons removed breast tissue and nearby lymph nodes after treatment, no remaining invasive cancer cells could be found under a microscope. The reported data shows that, for the primary measurement, 172 out of 394 people in the TX05 group and 185 out of 400 people in the Herceptin® group had no detectable invasive cancer remaining in their breast tissue at the time of surgery. Looking at lymph nodes specifically, the reported numbers were 164 people in the TX05 group and 153 people in the Herceptin® group meeting that measure. For the secondary measurement — called objective response rate — this looked at how much tumours shrank during treatment as measured by MRI scans. The reported data shows 332 out of the TX05 participants and 340 out of the Herceptin® participants had their tumours either disappear entirely or shrink by at least 30%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02032823 · results posted 8 December 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT02032823) enrolled 1,836 people in total — 921 received olaparib (a tablet-based medicine) and 915 received a placebo (a dummy pill with no active ingredient). The trial was measuring outcomes in people with a type of breast cancer linked to certain inherited gene changes (BRCA mutations), after they had already completed chemotherapy and surgery. The main thing the trial tracked was "invasive disease-free survival," which means how many people experienced their cancer coming back, a new cancer developing, or death during the study period. Several secondary (additional) outcomes were also measured, including whether cancer spread to distant parts of the body, overall survival (deaths from any cause), new cancers in other areas, and how tired participants reported feeling over time. The reported data shows that for the main outcome — counting people who had a cancer recurrence, new cancer, or died — 106 events occurred in the olaparib group compared with 178 in the placebo group. For cancer spreading to distant parts of the body, 89 events were recorded in the olaparib group versus 152 in the placebo group. For deaths from any cause, 75 occurred in the olaparib group compared with 109 in the placebo group. Regarding new cancers developing in other locations (such as the opposite breast or the ovaries), the numbers were generally small and similar or slightly lower in the olaparib group compared with the placebo group. For tiredness (measured using a standard questionnaire scored from 0 to 52, where a higher score means less fatigue), the reported data shows that scores changed only slightly from the starting point in both groups across all time points measured, with no large differences between the two groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00631852 · results posted 11 November 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 16 participants, all of whom completed the study — none dropped out. The trial was testing a preparation called LEAG (a form of American Ginseng Root) and was measuring changes in the levels of six different substances in the blood. These substances — Adiponectin, C-Reactive Protein (CRP), Hepatocyte Growth Factor (HGF), Insulin-like Growth Factor 1 (IGF-1), IGF-1 Receptor (IGF-1R), and Interleukin-10 (IL-10) — are proteins that the body produces and that researchers sometimes track to understand how the body is functioning. The trial measured how much these levels changed from the start of the study to the end of treatment. The reported data shows the following average changes in blood levels across the 16 participants: Adiponectin changed by 1,308 pg/ml (pg/ml is simply a unit for measuring tiny amounts of a substance in blood); CRP changed by 761 pg/ml; HGF changed by 1.25 pg/ml; IGF-1 changed by −144 pg/ml (meaning levels were lower at the end than at the start); IGF-1 Receptor changed by −364 pg/ml (also lower at the end); and IL-10 changed by 0.1 pg/ml. It is worth noting that the reported data does not include the starting (baseline) values or a comparison group, so these change figures cannot be put into a broader context from the data alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03633331 · results posted 15 October 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 93 adults who received a combination of palbociclib together with either letrozole or fulvestrant (hormone-based treatments). Ninety-two of the 93 participants completed the study. The trial was primarily looking at how often participants experienced serious side effects — specifically, side effects rated as grade 3 or higher (meaning significant or severe) according to a standard medical grading scale. It also tracked things like how long people stayed on treatment, whether doses needed to be changed, and how well participants kept to their prescribed doses. The reported data shows that the primary outcome — the proportion of participants who experienced a grade 3 or higher side effect at any point — was 0.756, meaning roughly 75.6 in every 100 participants. A related secondary measure reported that 62.6% of participants experienced a grade 3 or higher side effect specifically attributed to the study drugs. The reported data also shows that the middle point for "time to treatment failure" (that is, the point by which half the participants had stopped treatment due to a serious side effect, disease progression, or personal choice) was 450 days. Regarding how closely participants followed their dosing schedule, adherence was reported as 100% in the first treatment cycle, 94.3% in the second, and 97.6% in the third. For tumour response, the reported data shows that 55% of participants met the criteria for a measurable reduction in their cancer (either a complete or partial response confirmed on two assessments at least eight weeks apart). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02907918 · results posted 5 September 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 26 participants, all of whom completed the study. Every participant received a combination of medicines — palbociclib, letrozole, and trastuzumab, with some also receiving goserelin. The trial was measuring two main things: first, how many participants showed no remaining signs of invasive cancer in the breast tissue and lymph nodes after surgery (called a "pathologic complete response," or pCR); and second, how participants tolerated the treatment combination, including self-reported side-effect experiences over time. The reported data shows that out of 26 participants, 2 achieved a pathologic complete response — meaning no invasive tumour cells were found in the surgical tissue or lymph nodes at the time of surgery. Regarding side effects, the reported data shows that 13 participants experienced at least one serious (Grade 3 or 4) adverse event, which in general terms means a severe or life-threatening reaction. Individual serious side effects were each reported in small numbers of participants: 8 participants reported one particular side effect at that level, and several other specific side effects were each reported by 1 or 2 participants. The data does not provide the names of each individual side effect in the structured results submitted, so a full breakdown cannot be described here. The reported data also shows that participants filled in questionnaires about their symptoms at three points in time — before treatment began, at the start of the second treatment cycle, and at the end of the fourth cycle. Scores on these questionnaires were recorded on a scale of 0 (no symptoms) to 4 (very severe/very frequent). The average scores across different symptom areas ranged roughly from about 1.0 to 1.5 at each time point, though no further interpretation of what those changes mean has been reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03197935 · results posted 2 June 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 333 people with breast cancer — 168 in the placebo-plus-chemotherapy group and 165 in the atezolizumab-plus-chemotherapy group. The trial was measuring whether adding atezolizumab (an immunotherapy medicine) to standard chemotherapy before surgery made a difference in how many participants achieved what is called a "pathologic complete response" (pCR) — meaning that when surgeons examined the removed tissue, no active (invasive) cancer could be found in either the breast or the nearby lymph nodes. By the end of the study period, 121 participants in the placebo group and 136 in the atezolizumab group had completed the study. The reported data shows that, across all participants, 69 out of 168 people in the placebo-plus-chemotherapy group achieved a pCR, compared with 95 out of 165 people in the atezolizumab-plus-chemotherapy group. The trial also looked separately at a subgroup of participants whose tumours tested positive for a protein called PD-L1 (which some cancers produce). In that subgroup, the reported numbers were 37 out of the placebo group achieving a pCR, compared with 53 in the atezolizumab group. The trial also planned to measure longer-term outcomes — specifically how long participants went without their disease returning or worsening (called "event-free survival" and "disease-free survival") — but the reported data shows those figures were not available at the time the results were submitted to ClinicalTrials.gov, so no numbers can be provided for those measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02425891 · results posted 17 May 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT02425891) enrolled 902 people with breast cancer — 451 in each group. One group received a chemotherapy drug called nab-paclitaxel combined with a placebo (an inactive substance), and the other group received the same chemotherapy combined with atezolizumab (an immunotherapy medicine). The trial was measuring how long people went without their cancer growing (called progression-free survival), how long people lived overall (overall survival), and how many people's tumours shrank or disappeared. These outcomes were looked at both across all participants and separately in a subgroup whose tumours showed a protein called PD-L1. The reported data shows the following results. For time without the cancer growing (across all participants), the placebo group's median figure was 5.49 months and the atezolizumab group's was 7.16 months. In the PD-L1 subgroup, those figures were 4.96 months and 7.46 months respectively. For overall survival (the median time participants lived after joining the trial), the reported data shows 18.73 months in the placebo group and 21.03 months in the atezolizumab group across all participants; in the PD-L1 subgroup, the figures were 17.91 months and 25.43 months. ("Median" simply means the middle value — half of participants fell above it and half below.) Regarding tumour shrinkage or disappearance, 45.9% of the placebo group and 56.0% of the atezolizumab group across all participants met that measure; in the PD-L1 subgroup, the figures were 42.6% and 58.9%. It is worth noting that the trial records show zero participants in either group were recorded as having "completed" the study in the formal sense, meaning all 902 participants left the study before its scheduled completion — the reasons for this are not detailed in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02953860 · results posted 14 May 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 32 participants, all of whom received a combination of two medicines — fulvestrant and enzalutamide. All 32 participants completed the study with none dropping out. The trial was looking at how many participants showed a "clinical benefit" from the treatment combination at 24 weeks — meaning their cancer either shrank, disappeared, or stayed stable for at least 24 weeks. It also tracked how many participants were free from disease progression at 24 weeks, and recorded side effects experienced during the trial. The reported data shows that, out of 32 participants, 7 met the criteria for clinical benefit at the 24-week mark. Similarly, 7 participants were reported as being free from disease progression at 24 weeks. Regarding side effects (called adverse events in the trial), the reported data shows varying numbers of participants experienced different types of events — for example, 17 participants reported one category of side effect, 16 another, and smaller numbers (ranging from 5 to 11 participants) reported other categories. However, the specific details of what each of those side-effect categories referred to were not broken down in the data submitted to ClinicalTrials.gov, so a fuller description of each cannot be provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03051672 · results posted 27 April 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 8 participants, all of whom received the same treatment — a combination of the immunotherapy drug pembrolizumab and radiation therapy. All 8 participants started and completed the study. The trial was primarily looking at whether tumours in areas of the body *outside* the treated radiation zone showed signs of shrinking or disappearing — a phenomenon sometimes called an "abscopal effect." It also tracked how long participants went without their disease getting worse, how long they lived overall, and whether they experienced any severe side effects linked to the treatment. The reported data shows that the main outcome — the proportion of participants whose tumours outside the radiation area shrank or disappeared — was 0%. In other words, none of the 8 participants met the criteria for a measurable reduction in those tumours based on the measurement standards used in the trial. For the secondary outcomes, the reported median time before disease progression (that is, the middle-point figure for how long participants went before their condition worsened) was 1.4 months, and the median overall survival (the middle-point figure for how long participants lived from the time they joined the study) was 2.9 months. The reported data also shows that 0 participants experienced a Grade 4 treatment-related adverse event — meaning the most severe category of side effect linked to treatment was not recorded for any participant in this small group. It is worth noting that only 8 people took part in this trial, which is a very small number, and the results reported here reflect only this specific group under these specific conditions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02536794 · results posted 23 April 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people with metastatic (spread beyond the breast) HER2-negative breast cancer, including a subgroup with a type called triple-negative breast cancer (TNBC — meaning the cancer cells lack three common receptors). All 30 participants started treatment with a combination of two immunotherapy drugs, durvalumab (MEDI4736) and tremelimumab. The trial was primarily measuring how many participants' tumours shrank or disappeared in response to the treatment combination, and secondarily tracking how long participants lived, how long before the disease progressed, and what unwanted side effects occurred. The reported data shows that 4 out of 30 participants showed a measurable tumour response (meaning their tumours either completely disappeared or shrank by at least 30%) — this was true both for the overall HER2-negative group and for the triple-negative subgroup. For the secondary outcomes, the reported data shows that 5 participants experienced what the trial called "clinical benefit," meaning their tumours either shrank or remained stable for at least 12 weeks. The median time before the disease progressed was reported as 4.86 months, and the median overall survival (how long participants lived from the start of treatment) was reported as 11.3 months. Regarding side effects, the reported data shows that 27 participants experienced at least one side effect considered possibly related to the study drugs: 12 experienced moderate effects, 6 experienced severe effects, and 7 experienced life-threatening effects. No fatal events were reported in that category. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02569801 · results posted 23 April 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT02569801) enrolled 71 people with breast cancer across two groups: 36 received an investigational drug called GDC-0810, and 35 received fulvestrant (an existing hormone-blocking medicine). The trial was primarily measuring how long participants went without their cancer getting worse (called "progression-free survival"), both across all participants and specifically in those whose tumours had a particular gene change (ESR1 mutation). It also looked at secondary measures including overall survival, how many participants' tumours shrank, how long that shrinkage lasted, and how many participants experienced a broader "clinical benefit" from treatment. The reported data shows that for the two main (primary) outcome measures — progression-free survival in all participants, and progression-free survival in those with ESR1 mutations — no numerical results were submitted to ClinicalTrials.gov, so those figures are not available. Notably, zero participants in either group were recorded as having formally "completed" the study, with all participants listed as "not completed." For the secondary outcomes where numbers were provided: the reported data shows that 0% of participants in the GDC-0810 group had their tumour shrink (an "objective response"), compared with 8.6% in the fulvestrant group. When looking at a broader measure — participants whose disease shrank or stayed stable for at least 24 weeks (called "clinical benefit") — 16.7% in the GDC-0810 group and 31.4% in the fulvestrant group met this measure. Results for overall survival and duration of response were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00461773 · results posted 16 March 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled a very small number of participants — 3 people in a group receiving bevacizumab alone, and 2 people in a group receiving bevacizumab combined with letrozole. All 5 participants completed the study. The trial was measuring how breast tumours responded to these treatments given before surgery (sometimes called "neoadjuvant" treatment, meaning treatment given to shrink a tumour ahead of an operation), as well as whether breast-conserving surgery became possible and how the tumour tissue looked under a microscope after removal. The reported data shows the following for the main outcome — how many participants' tumours responded clinically during treatment: in the bevacizumab-alone group, 1 person had a complete response (tumour no longer visible), 2 had a partial response (tumour shrank by at least half), and none had stable or progressive disease. In the bevacizumab-plus-letrozole group, 0 had a complete response, 1 had a partial response, and 1 had stable disease (tumour neither shrank enough nor grew). For the imaging-based tumour assessment, 2 participants in each group showed a partial response on mammogram, and 1 in the bevacizumab-alone group had stable disease. Regarding the tumour tissue examined after surgery, no participants in either group had a complete disappearance of tumour in the removed specimen. For the secondary outcome looking at side effects graded as serious (grade 3 or 4), the reported data shows 0 participants in either group experienced these. The outcome measuring biological markers was listed but no numerical data was reported. It is important to note that with only 5 participants in total, this trial was extremely small, and the reported numbers reflect only those few individuals. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02878057 · results posted 27 January 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people with advanced breast cancer. Of those, 26 completed the study and 4 did not finish. The trial was measuring how long participants went without their cancer getting worse (called progression-free survival), how long they lived overall, how many showed a measurable reduction in their cancer, and how many experienced unwanted side effects. The reported data shows that, on average, participants went 4.9 months before their cancer progressed (grew or spread), and the average overall survival — meaning the time from the first dose until death or the last check-in — was 18 months. For the secondary measures, 11 out of 30 participants were reported to have had a meaningful reduction in their cancer (either their tumours disappeared entirely or shrank by at least 30%). A broader measure called disease control rate — which also counts participants whose cancer stayed stable and did not grow — was recorded for 20 out of 30 participants. Regarding unwanted events, the reported data shows that 15 out of 30 participants experienced some form of adverse event, which could include things like high blood pressure, protein in the urine, nausea, tiredness, or changes in liver-related blood tests. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02040857 · results posted 23 December 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT02040857) enrolled 162 people, all of whom received the drug palbociclib alongside standard hormone-based therapy (called adjuvant endocrine therapy) for breast cancer. The trial was primarily looking at how many participants stopped taking palbociclib early — not because their cancer changed, but because of side effects, tolerability issues, or choosing to withdraw from treatment. Of the 162 who started, 152 were considered evaluable for this main question, and 102 completed the study. The reported data shows that 31% of evaluable participants stopped palbociclib early for tolerability-related reasons over the two-year period — this was the trial's primary (main) finding. When broken down by the type of hormone therapy used alongside palbociclib, the reported discontinuation rate was 28% for those taking an aromatase inhibitor (one type of hormone-blocking tablet) and 35% for those taking tamoxifen (another type). A separate after-the-fact analysis, looking at all 162 enrolled participants rather than just the evaluable group, reported a discontinuation rate of 63%. Regarding side effects that were tracked as secondary measures: 54% of participants experienced a severe drop in white blood cells (called grade 3–4 neutropenia, meaning a significant reduction that can increase infection risk), 76% experienced fatigue of any level of severity, and 28% experienced hair loss of any level of severity — all recorded as treatment-related events. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00290745 · results posted 4 December 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 79 participants, all of whom had a type of early-stage breast condition called Ductal Carcinoma in Situ (DCIS — abnormal cells found in the milk ducts of the breast that have not spread). All participants received either tamoxifen or letrozole, two hormone-based medicines, before surgery. The trial was measuring whether the size of the DCIS changed over six months, using two different types of imaging: mammography (an X-ray of the breast) and MRI (a detailed scan using magnetic fields). Of the 79 who started, 67 completed the trial and 12 did not. The reported data shows that, at the six-month mark, the middle (median) change in tumour size as measured by mammography was a reduction of 5.0 mm, and by MRI it was a reduction of 0.8 cm³. For the secondary measures — which looked at how individual participants' tumours responded by MRI — at the three-month point, 13 participants had a very large response (more than 90% volume reduction), 10 had a large response (81–90% reduction), 27 had a partial response (20–80% reduction), and 17 had little change or their condition progressed. At six months, 22 participants had a very large response, 7 had a large response, 26 had a partial response, and 12 had little change or progression. The reported data also shows that tumour volume reductions were measured across different groups based on hormone receptor levels in the tumour tissue, with median reductions ranging from around 45.8% to 96.2% depending on the group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01565499 · results posted 18 November 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 83 people with breast cancer, all of whom received a chemotherapy drug called nab-paclitaxel before surgery. Of those 83 participants, 75 completed the study and 8 did not. The trial was primarily looking at how much cancer remained in the breast and nearby lymph nodes after treatment — this is known as "Residual Cancer Burden Grade III" (RCB-III), which refers to a larger amount of remaining cancer detected at surgery. The trial also tracked a number of secondary measures, including whether the cancer disappeared completely (called a pathological complete response, or pCR), how tumours appeared on scans, survival free from returning cancer, and whether some participants who had been told they would need a full breast removal were able to have a smaller, breast-conserving operation instead. The reported data shows that out of the 83 participants, 23 were found to have RCB-III (the highest level of remaining cancer) at the time of surgery. For the secondary outcomes, 6 participants were reported to have had a complete disappearance of cancer (pCR). When tumours were measured by MRI scan, 62 participants showed either a complete or partial reduction in tumour size; when measured by mammogram, that number was 49. The reported data also shows that 20 out of 30 participants who had initially been planned for a full mastectomy went on to have breast-conserving surgery instead. For survival free from invasive disease, the reported median follow-up figure was approximately 4.89 years, though detailed survival rate figures were not reported in the submitted data. It is worth noting that some of the numbers listed for the primary outcome measure appear to represent a breakdown across different categories (for example, the five figures of 23, 37, 14, 6, and 1 participants), but the labels for each of those categories were not included in the submitted data, so a full plain-English breakdown of those figures cannot be provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01745367 · results posted 27 October 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT01745367) enrolled 30 people in total — 22 in the group receiving tivozanib hydrochloride combined with paclitaxel (a chemotherapy drug), and 8 in the group receiving a placebo combined with paclitaxel. The trial was set up to compare the two groups on several measures, including how long participants went without their disease getting worse (called progression-free survival), how many participants' tumours shrank (objective response rate), how long any shrinkage lasted (duration of response), and how long participants lived overall (overall survival). It also looked at side effects and how the body processed the drugs. The reported data shows that none of the 30 participants formally "completed" the trial — all were recorded as not completing it. For the main measure (progression-free survival) and most of the secondary measures — including tumour response rates, duration of response, overall survival, and drug processing data — no numerical results were submitted to ClinicalTrials.gov, so those figures are not available to report here. The only outcome measure with numbers reported relates to side effects: in the tivozanib-plus-paclitaxel group, 19 out of 21 treated participants were recorded as experiencing non-serious adverse events (unwanted health effects considered not life-threatening), and 1 participant experienced a serious adverse event. In the placebo-plus-paclitaxel group, 8 out of 8 participants were recorded as experiencing non-serious adverse events, and 1 experienced a serious adverse event. Given that no results were submitted for most of the trial's key outcome measures, the reported data is very limited. The small number of participants and the absence of most outcome data make it difficult to draw any conclusions from this trial's registered results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01572038 · results posted 25 September 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT01572038) enrolled 1,436 people with HER2-positive breast cancer, all of whom received the same treatment combination: pertuzumab, trastuzumab, and a taxane (a type of chemotherapy). All 1,436 participants received at least one dose of the study drugs. The trial was primarily tracking the number of participants who experienced unwanted medical events (called adverse events) during and shortly after treatment, as well as deaths that occurred over the course of the study. The reported data shows that out of 1,436 participants, 1,419 experienced at least one treatment-emergent adverse event (meaning an unwanted medical event that appeared or got worse after starting the study drugs). Of those, 879 had moderate or severe events, and 535 had events classed as severe or worse. Regarding deaths, the reported data shows that 658 participants died over the course of the study, with 581 of those deaths attributed to a single broad category of causes. Within the first six months of starting treatment, 38 participants died. When looking at more serious adverse events (Grade 3 or higher — meaning severe to life-threatening), 676 participants experienced at least one such event. Of these, 286 experienced a serious adverse event that investigators considered related to the study treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00945061 · results posted 18 August 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 13 people in total — 12 in a group receiving intraoperative radiation therapy (radiation delivered during surgery) and 1 in a group receiving intracavitary balloon brachytherapy (radiation delivered via a small balloon placed inside the breast after surgery). All 13 participants completed the study. The trial was measuring how often cancer came back in the same breast after treatment — a outcome known as ipsilateral breast tumour recurrence, which can mean either leftover cancer cells growing back or a brand-new cancer forming in the same breast. The reported data shows that the primary outcome — the rate of cancer returning in the same breast — was measured at multiple time points. At most of those time points, 0% of participants in both groups were reported to have had a recurrence. However, at one reported time point, the data shows a recurrence rate of 9% in the intraoperative radiation therapy group (which, given 12 participants, would correspond to approximately one person) and 0% in the intracavitary balloon brachytherapy group. The specific time points for each measurement were not detailed in the submitted data, so the timing of that 9% figure cannot be confirmed from the information provided. It is worth noting that this was a very small trial — just 13 people across both groups — and the reported data shows only the numbers submitted to ClinicalTrials.gov without additional context about the study duration or participant characteristics. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02202746 · results posted 23 June 2020

According to the results reported on ClinicalTrials.gov, this trial looked at a drug called lucitanib (also known as CO-3810) in two different daily doses — 10 mg and 15 mg — given as a capsule. A total of 178 people took part: 109 in the 10 mg group and 69 in the 15 mg group. The trial was mainly measuring how long participants went without their cancer getting worse (called "progression-free survival"), and also tracked things like how many people's tumours shrank, how long those responses lasted, and how the body absorbed the drug in capsule versus tablet form. The reported data shows that, for the main measure, participants in the 10 mg group went a median of 93 days before their disease progressed or they died, while those in the 15 mg group had a median of 77 days. For tumour shrinkage (called objective response rate — meaning the percentage of people whose tumours shrank by a meaningful amount), the reported figures were 4.7% in the 10 mg group, 1.5% in the 15 mg group, and 3.5% across all participants combined. For people who had a response, the reported data shows it lasted a median of 175 days in the 10 mg group and 336 days in the 15 mg group. When looking at disease control — meaning the percentage of people whose disease either shrank or stayed stable for at least 12 weeks — the reported figures were 48.1% (10 mg), 34.3% (15 mg), and 42.8% across all patients. The drug absorption measurements comparing the capsule and tablet forms were also reported, but the submitted data includes duplicate figures for some of those time points, so a clear single summary cannot be drawn from what was provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02692209 · results posted 11 June 2020

According to the results reported on ClinicalTrials.gov, this trial involved 298 participants and looked at two types of breast imaging: standard digital mammography (called FFDM, which stands for Full Field Digital Mammography) and a combination of digital mammography plus a technology called DBT (Digital Breast Tomosynthesis, which produces a series of layered images of the breast). All 298 participants completed the study. Readers examined the same images using both approaches, and the trial measured how accurately each method could identify the correct location of a potentially cancerous area in the breast. The reported data shows that the main measurement used was something called the "Area Under the Curve" (AUC) — a number between 0 and 1 used to summarise how well a test correctly identifies both positive and negative cases, where a score of 1 would mean perfect accuracy and 0.5 would mean no better than chance. According to the results reported on ClinicalTrials.gov, the FFDM plus DBT combination scored 0.837, while FFDM alone scored 0.784 on this measure. No other outcome measures were included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02675231 · results posted 26 May 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT02675231) enrolled 237 people in total, with 79 participants assigned to each of three treatment groups. The groups were: (1) abemaciclib combined with trastuzumab and fulvestrant, (2) abemaciclib combined with trastuzumab only, and (3) trastuzumab combined with standard chemotherapy. The trial's main focus was measuring how long participants went without their cancer visibly growing or spreading — known as "progression-free survival" — and several secondary measures including how many participants were still alive at one, two, and three years, how many showed a measurable reduction in tumour size, and how long those reductions lasted. The reported data shows that for the primary measure of time without disease progression, the abemaciclib-plus-trastuzumab-plus-fulvestrant group had a median of 8.3 months, while both the abemaciclib-plus-trastuzumab group and the chemotherapy comparison group each had a median of 5.7 months. ("Median" here means the midpoint — half of participants in each group reached that time point before progression, and half had not yet.) For overall survival, the reported data shows that at one year, approximately 77% of participants in each abemaciclib group and approximately 70% in the chemotherapy group were still alive. At two years, those figures were around 56%, 56%, and 43% respectively, and at three years approximately 47%, 40%, and 30%. Regarding tumour shrinkage, about 33% of participants in the abemaciclib-plus-trastuzumab-plus-fulvestrant group showed a measurable reduction, compared with about 14% in each of the other two groups. Among those who did show a reduction, the reported duration of that response was a median of 12.5 months in the first group and 9.5 months in the second group; this figure was not reported for the chemotherapy group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03765996 · results posted 27 April 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT03765996) involved 36 people in total, split into two groups of 18. One group received a treatment called Decongestive Physiotherapy on its own, while the other group received Decongestive Physiotherapy combined with taping. The trial was measuring changes in arm size (volume) over the course of 20 treatment sessions, with the aim of tracking how limb volume shifted from the start of the study to the end. The reported data shows that limb volume was measured in millilitres, calculated from a series of arm circumference measurements taken at regular intervals along the arm. For the group receiving Decongestive Physiotherapy alone, the reported change in limb volume from the start to the end of the study was approximately 160 millilitres. For the group receiving Decongestive Physiotherapy plus taping, the reported change was approximately 148 millilitres. It is worth noting that 4 participants in the first group did not complete the study, while all 18 participants in the combined-treatment group did. No other outcome measure data was reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01892540 · results posted 25 February 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT01892540) enrolled 43 participants across two groups: 15 people in Cohort 1 (using a standard positioning device) and 28 people in Cohort 3 (using a current positioning device while a new one became available). Cohort 2, which was intended to test a new positioning device, had no participants enrolled. The trial was looking at how well a combined PET/MRI scan — a type of imaging that merges two scanning technologies — compared to the more established PET/CT scan for detecting cancer in the breast, and whether adding different scan types together improved accuracy. The reported data shows that for Cohorts 1 and 2, the primary measures comparing the two scanning methods using a value called SUV (a number that reflects how much of a tracer substance is taken up by tissue) had no numerical results submitted to ClinicalTrials.gov — that data was not reported. For Cohort 3, the reported data shows results for how well different combinations of scan types detected lesions (areas of concern). When looking at "specificity" — meaning how well the scan correctly identified areas that were *not* cancerous — the reported figures were: 0% for a single scan type alone (DCE-MRI), 89% when two scan types were combined (in two different combinations), and 100% when all three scan types were used together. For "sensitivity" — meaning how well the scan correctly identified areas that *were* cancerous — the reported figures were: 100% for DCE-MRI alone, 95% for one two-scan combination, 86% for another two-scan combination, and 85% when all three were combined. It is worth noting that these figures relate only to Cohort 3, and the data for Cohorts 1 and 2 on the main comparison measures was not submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00944528 · results posted 12 February 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 35 people in total across three groups, each receiving a different dose level of a single-session radiation treatment (called radiosurgery) directed at breast tissue. Nine people started in the lowest dose group, 10 in the middle dose group, and 16 in the highest dose group. The trial was primarily measuring what the highest radiation dose could be given without causing unacceptable short-term side effects or wound healing problems — this is known as the "maximum tolerated dose." It also looked at how the treated breast appeared at three years after treatment, as judged by a doctor. The reported data shows that the maximum tolerated dose was identified as 21 Gray (Gray is simply the unit used to measure radiation doses). For the cosmetic outcome — meaning how the breast looked at three years, rated by a doctor as either "excellent" or "good" — the reported figures varied by dose group. In the lowest dose group, 71% of participants were rated as having an excellent or good cosmetic outcome. In both the middle and highest dose groups, 100% of participants were rated as having an excellent or good cosmetic outcome. The trial also intended to measure local control (whether the cancer stayed away in the treated area), but the reported data shows no numbers were submitted for that outcome. Two additional exploratory measures — collecting tissue samples and taking MRI scans before and after treatment to study how the body responds to radiation — were listed as planned outcomes, but the reported data shows no results were submitted for these either. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01490892 · results posted 13 January 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 219 participants, and all 219 completed the study with no drop-outs. The trial was looking at breast lesions (lumps or abnormal areas) and testing whether different ultrasound imaging techniques could distinguish between lesions that were cancerous (malignant) and those that were not (benign). The imaging methods compared included a newer approach called 3D Subharmonic Imaging (SHI), standard Harmonic Imaging (HI), and Power Doppler Imaging (PDI) — all of which use sound waves to look at blood flow activity around a lesion, with SHI using a contrast agent injected into the bloodstream to improve the picture. The reported data shows that across the different imaging methods, varying numbers of lesions were counted in each category. For one imaging approach, 69 lesions were recorded in one category, 24 in another, and 126 in a third. For a second imaging approach, the reported figures were 58, 25, and 136 lesions respectively. A third approach recorded 3, 5, and 211 lesions across those same groupings. The trial noted that these results were to be looked at in a descriptive way rather than with formal statistical testing. For the secondary measure — which looked at changes in the volume of blood vessels around lesions using SHI signal strength (measured in decibels, a unit of signal intensity) — the reported data shows four values: 1.83, 1.50, 1.72, and 1.26 dB. Further detail about exactly what each individual number refers to within these categories was not fully specified in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00600340 · results posted 30 December 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 564 people with breast cancer — 285 in a group receiving bevacizumab plus paclitaxel, and 279 in a group receiving bevacizumab plus capecitabine. The trial was primarily measuring how long participants lived after joining the study (called "overall survival"), and also looked at secondary measures such as how long participants were observed and how their tumours responded to treatment. The reported data shows that, for overall survival, the bevacizumab plus paclitaxel group had a median survival time of around 30 months (29.5–30.2 months depending on which analysis group was used), while the bevacizumab plus capecitabine group had a median survival time of around 26 months (26.0–26.1 months). "Median" here simply means the point at which half the participants in each group had died and half were still alive. The reported data also shows that participants were followed up for a median of roughly 54–56 months in both groups. For tumour response — that is, whether tumours shrank or stayed stable during treatment — the reported numbers show that in the paclitaxel group, 10 people had a complete response (tumour disappeared), 115 had a partial response (tumour shrank), 127 had stable disease, 18 had their disease get worse, and 15 were unable to be evaluated. In the capecitabine group, the corresponding numbers were 2, 74, 138, 47, and 18 respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01808573 · results posted 11 December 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT01808573) enrolled 621 people with breast cancer — 307 assigned to receive neratinib plus capecitabine, and 314 assigned to receive lapatinib plus capecitabine. The trial was measuring how long participants lived without their cancer getting worse (called progression-free survival), how long they lived overall, and a number of other things including tumour response rates and whether people needed treatment for cancer that had spread to the brain. The reported data shows that, for the main measure of time without cancer worsening (tracked up to 24 months), the neratinib plus capecitabine group averaged 8.8 months and the lapatinib plus capecitabine group averaged 6.6 months. For overall survival (tracked up to 48 months), the reported averages were 24.0 months and 22.2 months respectively. These averages were calculated using a method that looks at the area under a survival curve — essentially a way of summarising survival time across the whole group, not a prediction for any individual. The reported data also shows that, among participants with measurable disease at the start, 32.8% in the neratinib group and 26.7% in the lapatinib group showed a measurable tumour shrinkage response. A broader measure — counting people whose disease either responded or stayed stable for at least 24 weeks — was 44.5% for the neratinib group and 35.6% for the lapatinib group. Among those who did respond, the response lasted an average of 8.54 months in the neratinib group and 5.55 months in the lapatinib group. For the measure tracking whether participants needed an intervention for cancer that had spread to the brain, 22.76% of the neratinib group and 29.19% of the lapatinib group reached that point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02322814 · results posted 13 November 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02322814) enrolled 169 people across five groups, testing different combinations of cancer medicines — cobimetinib, paclitaxel, nab-paclitaxel, and atezolizumab — in people with triple-negative breast cancer. The trial was organised into three cohorts: Cohort I compared cobimetinib plus paclitaxel against a placebo plus paclitaxel; Cohort II tested cobimetinib, paclitaxel, and atezolizumab together; and Cohort III tested cobimetinib, nab-paclitaxel, and atezolizumab together. The trial measured how long it took for the cancer to stop responding to treatment (called progression-free survival), how many participants' tumours shrank or disappeared (called overall response), and how long participants lived overall (called overall survival), among other things. Notably, the reported data shows that zero participants in all groups were recorded as having "completed" the study, meaning all participants left the study before its scheduled end — the data does not explain why for each individual. The reported data shows that, for Cohort I, participants who received cobimetinib plus paclitaxel went an average of about 23.7 weeks before their cancer progressed, compared with about 16.4 weeks for those on placebo plus paclitaxel. In terms of tumour shrinkage or disappearance in Cohort I, about 38% of those on cobimetinib plus paclitaxel had a confirmed response, compared with about 21% on placebo plus paclitaxel. For Cohorts II and III, the confirmed overall response rates were reported as approximately 38% and 32% respectively. For overall survival, the reported figures were approximately 16.7 months (Cohort I cobimetinib arm), 19.6 months (Cohort I placebo arm), 11 months (Cohort II), and 15.6 months (Cohort III). How long responses lasted (duration of response) ranged from about 5.8 months in Cohort II to about 39 months in the safety run-in group, though the safety run-in group was small (16 people) and was not a comparison group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02472353 · results posted 16 October 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people with breast cancer — 14 in a standard care group and 16 in a group that received standard care plus metformin (a medication more commonly associated with diabetes). The trial was looking at whether adding metformin to a chemotherapy drug called doxorubicin had any relationship with changes in how well the heart's left ventricle (the main pumping chamber) was working. This was measured using an ultrasound of the heart called an echocardiogram, specifically looking at a reading called "left ventricular ejection fraction" (LVEF) — essentially a measure of how much blood the heart pumps out with each beat. Of the 30 who started, 20 completed the trial (10 in each group). The reported data shows that the primary outcome measured the number of participants whose LVEF dropped by 5% or less — meaning their heart pumping function stayed relatively stable during treatment. According to the results reported on ClinicalTrials.gov, 4 out of the standard care group and 5 out of the metformin plus standard care group met this measure. No secondary outcome data appears to have been reported in the submitted results. It is worth noting that the numbers involved are very small, and no additional outcome data beyond this single measure was included in the submission. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01891357 · results posted 17 September 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT01891357) enrolled 64 people who had been diagnosed with HER2-positive breast cancer. All participants received the same treatment combination: paclitaxel, lapatinib, and trastuzumab. The trial's main goal was to measure something called a "pathological complete response" (pCR) — this means checking, at the time of surgery, whether any cancer could still be found in the breast tissue and nearby lymph nodes after the treatment period had finished. Of the 64 people who started, 61 completed the study and 3 did not. The reported data shows that the primary measure of pCR (defined as no remaining invasive cancer in either the breast or the lymph nodes, written as ypT0/is, ypN0) was recorded in 19 out of the participants. The reported data also shows two further ways of counting a response: under a stricter definition (no cancer at all in the breast or lymph nodes, ypT0, ypN0), 27 participants met that threshold; and under a looser definition looking only at the breast tissue (ypT0/is), 25 participants met that threshold. It is worth noting that the trial reported three separate numbers for what appears to be three different definitions of response, but the total number of participants each figure applies to was not clearly separated in the submitted data, so these figures should be interpreted with that in mind. The reported data shows that results for the two secondary outcomes — how long people went without a disease event (event-free survival) and how long people lived overall (overall survival) — were not submitted to ClinicalTrials.gov, so those figures cannot be described here. Similarly, the exploratory genetic marker analysis was listed but no results were reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00756717 · results posted 4 September 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 22 participants, all of whom received a treatment called MK-0752. Twenty participants completed the trial, while two did not finish. The trial was measuring how many participants experienced at least one adverse event (that is, any unwanted or unexpected health occurrence) over a 24-day observation period and at an initial post-operative visit. The reported data shows that the primary outcome — the number of participants who experienced at least one adverse event — returned two separate figures: 15 participants and 5 participants. However, the submitted data does not clearly label what distinguishes these two numbers from one another (for example, whether they refer to different time points or different categories of events), so it is not possible to describe the distinction between them without guessing. The data as submitted does not include any secondary outcome measures to report on. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01706081 · results posted 29 August 2019

According to the results reported on ClinicalTrials.gov, this trial involved 82 people in total — 40 in an acupuncture group and 42 in a wait-list group (meaning they did not receive acupuncture during the study period). All 82 participants completed the study with no drop-outs recorded. The trial was looking at lymphoedema — a condition involving swelling caused by a build-up of fluid — specifically in the arm. It measured changes in arm swelling over a six-week period using two methods: arm circumference (measured in centimetres) and a technique called bioimpedance, which uses a mild electrical signal to estimate how much fluid is in the affected limb compared to the other arm. The reported data shows that, for arm circumference, the acupuncture group had an average measurement of 4.74 cm at the start of the study and 4.29 cm at six weeks. The wait-list group measured 4.82 cm at the start and 4.76 cm at six weeks. For the bioimpedance readings (measured in ohms, a unit of electrical resistance), the acupuncture group recorded 38.6 ohms at the start and 35.9 ohms at six weeks, while the wait-list group recorded 42.2 ohms at the start and 40.3 ohms at six weeks. These numbers represent the group averages as recorded at each point in time. The reported data also notes that all 40 participants in the acupuncture group and all 42 in the wait-list group were evaluated for unwanted side effects, though no further detail on those findings was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02437318 · results posted 13 August 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02437318) enrolled 572 people in total — 284 received alpelisib combined with fulvestrant, and 288 received a placebo combined with fulvestrant. Participants were divided into groups based on whether their tumour carried a specific gene change called a PIK3CA mutation (detected through tumour tissue testing). The trial was primarily measuring how long people in the PIK3CA-mutant group went without their cancer growing or spreading — a measure called "progression-free survival." The reported data shows that, among participants whose tumour tissue tested positive for the PIK3CA mutation, the median time before disease progression or death was 11.0 months in the alpelisib + fulvestrant group, compared with 5.7 months in the placebo + fulvestrant group. Median overall survival (the midpoint for how long people lived from the start of the trial) was reported as 39.3 months versus 31.4 months in these same two groups. In the group whose tumours did not carry the PIK3CA mutation, the reported median progression-free survival figures were very close — 7.43 months for alpelisib + fulvestrant and 7.23 months for placebo + fulvestrant — and overall survival was 37.29 months versus 34.30 months respectively. The reported data also shows several secondary measurements. The proportion of participants whose tumours shrank (called the overall response rate) was 26.6% in the PIK3CA-mutant alpelisib group versus 13.4% in the placebo group; in the non-mutant group it was 20.9% versus 12.9%. A broader measure — the "clinical benefit rate," which counted people whose disease shrank or stayed stable for more than 24 weeks — was 61.5% versus 44.8% in the PIK3CA-mutant groups, and 53.9% versus 49.1% in the non-mutant groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01160211 · results posted 15 July 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 369 people with breast cancer across three treatment groups: one group received a combination of lapatinib, trastuzumab, and an aromatase inhibitor (124 people); a second group received lapatinib plus an aromatase inhibitor (123 people); and a third group received trastuzumab plus an aromatase inhibitor (122 people). The trial was primarily measuring how long participants went without their disease getting worse — called "progression-free survival" — comparing the triple combination group against the trastuzumab plus aromatase inhibitor group. It also looked at how many people's disease progressed or who passed away, as well as overall response rates and clinical benefit rates across all three groups. The reported data shows that the middle point (median) time without disease progression was 11.0 months in the triple combination group, compared with 5.6 months in the trastuzumab plus aromatase inhibitor group. When all three groups were compared as a secondary measure, the reported median progression-free survival figures were 11.1 months for the triple combination, 8.3 months for lapatinib plus aromatase inhibitor, and 5.7 months for trastuzumab plus aromatase inhibitor. The reported data shows that 32.3% of participants in the triple combination group had their tumour shrink or disappear (the "overall response rate"), compared with 22.8% in the lapatinib plus aromatase inhibitor group and 17.2% in the trastuzumab plus aromatase inhibitor group. The "clinical benefit rate" — meaning the percentage of people whose disease either responded or stayed stable for at least six months — was reported as 51.6%, 43.1%, and 34.4% for those same three groups respectively. Overall survival event numbers were reported, but median overall survival figures were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02096588 · results posted 26 June 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 31 people with early-stage breast cancer who were receiving a type of chemotherapy called anthracycline-based treatment. Fifteen participants were given simvastatin (a cholesterol-lowering medicine) alongside their chemotherapy, while 16 received chemotherapy without any additional drug. The trial was measuring whether taking simvastatin at the same time as chemotherapy made a difference to the heart's pumping function — specifically a measure called Global Longitudinal Strain (GLS), which is a way of assessing how well the heart muscle is squeezing. By the end of the study, 13 people in the simvastatin group and 15 in the no-drug group had completed the trial. The reported data shows that the primary measurement — the change in GLS from before chemotherapy to 2–3 weeks after finishing four cycles of treatment — was 0.42 percentage points in the simvastatin group and 1.11 percentage points in the no-drug group. A higher number here reflects a greater change in that heart function measure over the course of the study. For the secondary outcome looking at side effects, the reported data shows that all 15 participants in the simvastatin group were counted as having experienced at least one adverse event (an unwanted or unexpected health event recorded during the trial); no corresponding figure was reported for the no-drug group. For the third outcome — tracking whether cancer came back over time (called recurrence-free survival) — the data was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03456427 · results posted 5 April 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT03456427) enrolled 36 participants, with 33 completing the study and 3 not completing it. The trial was comparing two different ways of applying compression during a mammogram (a breast X-ray): one where the patient controls the compression themselves (called Patient-Assisted Compression), and one where the mammography technologist applies the compression as usual (Technologist Compression). Each participant had both methods applied, so the same group of people was measured under both conditions. The reported data shows that for the primary measure — whether the overall image quality was acceptable — 30 out of 33 participants produced acceptable images using Patient-Assisted Compression, while all 33 out of 33 produced acceptable images using Technologist Compression. For the secondary measure looking at whether any images needed to be retaken, the reported data shows 1 participant required a repeat image under Patient-Assisted Compression, compared to 0 under Technologist Compression; 30 participants needed no repeat images under Patient-Assisted Compression, and 30 under Technologist Compression. For the secondary measure examining specific image quality features (called "mammographic attributes"), the reported numbers across the various attributes were broadly similar between the two methods, with small numerical differences across categories, though the data as submitted does not provide enough labelling detail to describe each individual attribute category with certainty. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01605396 · results posted 25 March 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 80 people in total — 40 in each of two groups. One group received a three-drug combination (ridaforolimus, dalotuzumab, and exemestane), while the other received two drugs (ridaforolimus and exemestane). The trial was primarily measuring how long participants went without their cancer growing or spreading — a measure called "progression-free survival" — and also looked at a number of secondary measures, including changes in tumour size, the proportion of participants whose tumours shrank, and how long participants lived overall. Notably, no participants were recorded as having formally "completed" the study, meaning all 80 in each group left the trial before its scheduled end, most likely due to disease progression as per the trial's design. The reported data shows that, for the primary measure, participants in the three-drug group went a median (the midpoint value across the group) of about 23.3 weeks before their disease progressed or they passed away, compared with about 31.9 weeks in the two-drug group. For the secondary measures, the three-drug group showed an average reduction in the combined size of target tumours of about 19.3% at week 16, compared with a 10.7% reduction in the two-drug group. When looking at the proportion of participants whose tumours shrank meaningfully (called the objective response rate), the reported data shows 15% of participants in the three-drug group met this threshold, compared with 25% in the two-drug group. For overall survival — how long participants lived — the data was reported as "not available" for both groups, meaning a median figure could not be calculated from the data submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01997333 · results posted 8 March 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT01997333) compared two treatments — capecitabine and CDX-011 (also known as glembatumumab vedotin) — in people with a type of breast cancer. A total of 109 participants were assigned to the capecitabine group and 218 to the CDX-011 group, making 327 people in total. The main thing the trial was measuring was how long participants went without their disease getting worse (called "progression-free survival"), and a number of secondary measures were also recorded, including how many participants' tumours shrank, how long that shrinkage lasted, how long participants lived overall, and what side effects occurred. The reported data shows that for the primary measure — time until disease progression or death — the median figure (the midpoint where half the participants did better and half did worse) was 2.8 months in the capecitabine group and 2.9 months in the CDX-011 group. For the percentage of participants whose tumours shrank (objective response rate), the reported figures were 21% in the capecitabine group and 26% in the CDX-011 group. Among those whose tumours did shrink, the reported median duration of that response was 4.2 months for capecitabine and 2.8 months for CDX-011. The reported median overall survival — time from the start of the trial to death from any cause — was 8.7 months for capecitabine and 8.9 months for CDX-011. Regarding side effects, the data indicates that adverse events were recorded across both groups, though the full breakdown of severity and type was not provided in the summarised figures available here. Some pharmacokinetic measurements (how the drug moved through the body) were also reported for CDX-011, but these are highly technical figures not easily described without specialist context. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02278120 · results posted 26 February 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 672 people in total — 335 in the group receiving ribociclib combined with hormone therapy (either a non-steroidal aromatase inhibitor or tamoxifen, plus goserelin), and 337 in the group receiving a placebo combined with the same hormone therapy. The trial was measuring how long participants went without their cancer growing or spreading (called "progression-free survival"), as well as several other measures including overall survival, how many participants' tumours shrank, and how long any shrinkage lasted. The reported data shows that for the main outcome — the time until the cancer progressed or a participant died — the median figure in the ribociclib group was 23.8 months, compared with 13.0 months in the placebo group. (Median here means the point at which half the participants in each group had experienced an event.) For overall survival — the time from joining the trial until death from any cause — the reported median for the ribociclib group was listed as "NA" (meaning a median figure had not yet been reached at the time of analysis), while the placebo group's median was reported as 40.9 months. The reported data also shows that 40.9% of participants in the ribociclib group and 29.7% in the placebo group had their tumour shrink meaningfully (the "overall response rate"). A broader measure — including participants whose disease remained stable for at least 24 weeks — was reported at 79.1% for the ribociclib group and 69.7% for the placebo group. The median time until a response first appeared was not reported for either group, while the median time that a response lasted was reported as 21.3 months for the ribociclib group and 17.5 months for the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02129556 · results posted 15 February 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02129556) looked at combining two medicines — MK-3475 (also known as pembrolizumab, a type of immunotherapy) and trastuzumab (a targeted therapy) — in people with HER2-positive breast cancer. A total of 58 people took part across four groups: 3 people received a lower dose in an early safety phase, 3 received a higher dose in that same phase, 40 were enrolled in the main phase and had a protein called PD-L1 present in their tumour, and 12 were in the main phase without that protein. The trial measured whether certain side effects occurred at unacceptable levels (in the early phase), and then how many people's tumours shrank or disappeared (called the objective response rate) in the main phase. The reported data shows that in the early safety phase, none of the 6 participants experienced what the trial defined as a "dose-limiting toxicity" — that is, a serious side effect severe enough to limit the dose. In the main phase, the proportion of participants whose tumours showed a confirmed response was reported as 0.15 (roughly 15 in every 100) among those with the PD-L1 protein present, and 0.00 (no responses) among those without it. For the small early-phase group combined, the reported response proportion was 0.17. Among those who did respond, the reported duration of that response was 23.1 months in the early-phase group and 3.5 months in the PD-L1-positive main-phase group; no duration figure was reported for the PD-L1-negative group, as no responses occurred there. The reported data shows that across all groups, the median time until the disease progressed was between 2.5 and 2.7 months. The disease control rate — meaning the proportion of participants whose disease either responded or stayed stable for at least 24 weeks — was reported as 0.17 for the early-phase group, 0.25 for the PD-L1-positive main-phase group, and 0.00 for the PD-L1-negative group. Progression-free survival figures (the time from first treatment until disease worsened or death) matched the time-to-progression numbers across all groups, ranging from 2.5 to 2.7 months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02924883 · results posted 12 February 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02924883) enrolled 202 people with cancer — 133 were assigned to receive trastuzumab emtansine combined with atezolizumab, and 69 received trastuzumab emtansine combined with a placebo (an inactive substitute). The trial was primarily measuring two things: how long participants went without their disease getting worse (called progression-free survival), and how many participants experienced any unwanted medical events (called adverse events) during the study. None of the participants were recorded as having formally "completed" the study, meaning all had either withdrawn, experienced disease progression, or the study ended before a completion milestone was recorded. The reported data shows that participants in the placebo group went a median of 6.8 months before their disease progressed or they died, compared with 8.2 months in the atezolizumab group. (Median means half the participants in each group had an event before that time, and half after.) Regarding adverse events — any unwanted medical occurrence during the study — 97.0% of participants in the placebo group and 99.2% in the atezolizumab group had at least one such event recorded. For the secondary outcomes, approximately 43.5% of the placebo group and 45.5% of the atezolizumab group showed a measurable reduction in tumour size. The overall survival figures and the duration of tumour response were both listed as "not available" in the reported data, meaning those results were not provided. Blood concentration levels of trastuzumab emtansine were also measured and reported as 73.2 micrograms per millilitre in the placebo group and 63.9 in the atezolizumab group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00553410 · results posted 29 January 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT00553410) enrolled 4,884 people in total — 2,441 in one group and 2,443 in the other. Participants were randomly assigned to take a hormone-blocking medicine called letrozole either continuously (every day without a break) or intermittently (with planned breaks). The main thing the trial was measuring was "disease-free survival" — meaning how many people went a set period of time without their breast cancer coming back, a new cancer appearing, or dying. The reported data shows that for the primary measure — disease-free survival — 87.5% of people in the continuous letrozole group and 85.8% in the intermittent group reached the follow-up point without one of those events occurring. For overall survival (the proportion still alive, regardless of cancer status), the reported figures were 93.7% for the continuous group and 94.3% for the intermittent group. The trial also measured how long people went without the cancer spreading to distant parts of the body: 92.5% in the continuous group and 93.2% in the intermittent group remained free of such spread. Finally, looking specifically at breast cancer returning or a new breast cancer appearing (setting aside other cancer types), the reported figures were 91.2% for continuous and 90.9% for intermittent letrozole. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02287675 · results posted 9 January 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02287675) enrolled 40 people in total — 22 received a radioactive tracer called Sulfur Colloid and 18 received a tracer called Lymphoseek. All participants completed the trial with no drop-outs. The trial was measuring how these two tracers behaved when injected near a tumour site to help surgeons locate "sentinel lymph nodes" — the first lymph nodes that fluid drains to from a tumour, which are checked to see whether cancer has spread. The reported data shows that the two tracers moved through the body at different speeds. For injection site clearance (how quickly the tracer left the injection spot and reached the lymph node), Lymphoseek recorded an average of 1.78 minutes compared to 0.045 minutes for Sulfur Colloid. For how long it took the tracer to reach its peak level inside the sentinel lymph node, Lymphoseek averaged 59.28 minutes and Sulfur Colloid averaged 86.46 minutes. For the secondary outcomes, the reported data shows that during surgery, 9 sentinel lymph nodes were detected in the Lymphoseek group compared to 22 in the Sulfur Colloid group. The ratio of radioactive signal measured in the lymph node compared to the injection site was 0.11 for Lymphoseek and 0.26 for Sulfur Colloid. Patient-reported discomfort at the injection site (on a 0–10 scale, where higher means more discomfort) averaged 0.53 for Lymphoseek and 1.57 for Sulfur Colloid. Regarding the pathology check of removed lymph nodes for signs of cancer spread, 2 nodes in the Lymphoseek group and 0 in the Sulfur Colloid group were reported as positive, while 7 and 22 nodes respectively were reported as negative; the full breakdown of the remaining nodes was not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00876395 · results posted 19 December 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 719 people with breast cancer across two groups: 480 people received everolimus combined with paclitaxel and trastuzumab, while 239 people received a placebo combined with paclitaxel and trastuzumab. The trial was primarily measuring how long participants went without their cancer getting worse (called "progression-free survival"), both across all participants and within a smaller subgroup whose tumours were classified as hormone receptor-negative. It also tracked how long participants lived overall, and what proportion showed a measurable shrinkage or disappearance of their tumour. The reported data shows that, looking at all participants, the average time before the cancer progressed was 14.95 months in the everolimus group and 14.49 months in the placebo group. In the hormone receptor-negative subgroup, the reported figures were 20.27 months for the everolimus group and 13.08 months for the placebo group. For overall survival — meaning how long participants lived from the start of the trial — the reported data shows 48.56 months in the everolimus group and 49.97 months in the placebo group across all participants. In the hormone receptor-negative subgroup, overall survival was reported as 56.97 months for the everolimus group and 41.63 months for the placebo group. The reported data also shows that the proportion of participants whose tumour shrank or disappeared was 67.1% in the everolimus group and 69.0% in the placebo group across all participants. In the hormone receptor-negative subgroup, those figures were 73.1% and 70.9% respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02472964 · results posted 30 October 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT02472964) enrolled 493 people with HER2-positive breast cancer — 246 in the Herceptin® plus taxane (chemotherapy) group and 247 in the HerMyl 1401O (trastuzumab biosimilar) plus taxane group. The trial was run in two parts, each lasting roughly 24 weeks. The main thing being measured was how tumours responded to treatment by Week 24, using a standard set of rules called RECIST 1.1, which categorises each patient's tumour as having completely disappeared, shrunk, stayed the same, or grown. The reported data shows the following tumour response counts at Week 24. In the Herceptin® group: 0 participants had a complete response (tumour fully disappeared), 146 had a partial response (tumour shrank by at least 30%), 49 had stable disease (no meaningful change), 20 had progressive disease (tumour grew), and 13 could not be evaluated. In the HerMyl 1401O trastuzumab group: 3 participants had a complete response, 157 had a partial response, 48 had stable disease, 9 had progressive disease, and 13 could not be evaluated. No secondary outcome measure results were included in the data submitted to ClinicalTrials.gov, so those figures cannot be reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01394211 · results posted 26 July 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 2 participants in a single treatment group receiving a type of drug therapy (described as a "neoadjuvant enzyme inhibitor") given before surgery. The trial was measuring how well the treatment reduced or eliminated cancer in the breast and nearby lymph nodes before surgery, as well as whether it reduced tumour activity (measured by a marker called Ki-67, which reflects how fast cancer cells are growing) and whether it reduced the overall stage of the cancer by the time of surgery. The reported data shows that neither of the 2 participants completed the trial — both withdrew or did not finish for reasons that were not detailed in the data. Because no participants completed the study, no results were recorded for any of the outcome measures: the primary measure (whether cancer was completely cleared from the breast and lymph nodes) and both secondary measures (tumour activity changes and reduction in cancer stage) all show no data. The numbers for these outcomes were not reported. It is worth noting that with only 2 people enrolled and no completions, this trial was very small and did not generate the results it was originally designed to produce. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02019277 · results posted 23 July 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT02019277) enrolled 50 participants, all of whom received a combination of three medicines: trastuzumab, pertuzumab, and a taxane (a type of chemotherapy). The trial had one treatment group only — there was no comparison or placebo group. Of the 50 who started, 38 completed the study and 12 did not. The trial was primarily measuring how many participants experienced unwanted medical events (called adverse events) during treatment, and secondarily tracking things like how tumours responded to treatment and how long participants went without their disease getting worse. The reported data shows that 100% of participants experienced at least one adverse event of any kind during the study, and 54% experienced what was classified as a serious adverse event — meaning an event that led to hospitalisation, was life-threatening, caused lasting disability, or was otherwise considered significant. On the tumour response measures, 73.3% of participants were recorded as having their tumour either disappear completely or shrink by a meaningful amount. The reported data shows that 60% of participants experienced disease progression (their cancer grew or spread) or died during the study period. The median time from the start of treatment until disease progression or death was reported as approximately 17 months (median meaning half the participants reached this point sooner and half later). Around 18% of participants died during the study from any cause. The median overall survival figure — how long participants lived from the start of treatment — was not able to be calculated and was reported as not available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02273973 · results posted 21 May 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT02273973) enrolled 334 people with breast cancer — 166 received a combination of taselisib and letrozole, and 168 received a placebo together with letrozole. The trial was measuring two main things before surgery (called neoadjuvant therapy): first, how many participants' tumours shrank on an MRI scan by a defined amount (called an "objective response"); and second, how many had no detectable invasive cancer remaining in the breast or nearby lymph nodes when surgeons examined the removed tissue after treatment (called a "total pathologic complete response"). These measurements were looked at both across all participants and separately in a subgroup who had a specific gene change (called a PIK3CA mutation) in their tumour. The reported data shows that, looking at MRI scans across all participants, 50.0% in the taselisib-plus-letrozole group showed an objective response, compared with 39.3% in the placebo-plus-letrozole group. In the PIK3CA-mutated subgroup specifically, those figures were 56.2% versus 38.0%. For the complete absence of invasive cancer at surgery, the numbers were much smaller across both groups — 1.8% in the taselisib group versus 0.6% in the placebo group overall, and 1.4% versus 0% in the PIK3CA-mutated subgroup. Among participants whose tumours did not carry that gene change (the "wildtype" subgroup, reported as a secondary outcome), the objective response rates were 45.7% versus 40.4%, and the complete response at surgery was 2.2% versus 1.1%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01776008 · results posted 8 May 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 16 women who received a combination of three drugs — MK2206, anastrozole, and goserelin acetate — before surgery for breast cancer. Fourteen of the 16 participants completed the study, while two did not finish. The trial was primarily measuring whether the combination treatment led to what researchers call a "pathological complete response" — meaning no detectable invasive cancer cells remaining in the breast tissue or nearby lymph nodes at the time of surgery. The reported data shows that, out of all participants, zero achieved a pathological complete response. For the secondary outcomes — including the rate of clinical response (tumour shrinkage measured by physical examination) and radiological response (tumour shrinkage measured by imaging such as mammogram or ultrasound) — no numerical results were reported in the submitted data. Regarding side effects, the reported data shows that 6 participants experienced at least one adverse event (an unwanted health event) rated as grade 3 or higher — meaning considered severe — during treatment, and 2 participants experienced adverse events of a particular type at that severity level. The trial did not report numbers for two other planned measurements: changes in a tumour activity marker called Ki67, and changes in a measure of cell death called the apoptotic index. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02279108 · results posted 9 April 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 100 people with breast cancer, split into two equal groups of 50. The trial was comparing two methods for finding sentinel lymph nodes — the small nodes near a tumour that surgeons check to see if cancer has spread. One group had nodes identified using a combination of a green dye called indocyanine green (ICG) and a radioactive tracer (isotope), while the other group had nodes identified using the radioactive tracer alone. The main question the trial was measuring was how many patients in each group had fewer than two lymph nodes detected during surgery. The reported data shows that in the combined dye-and-tracer group, 22 out of 50 patients had fewer than two lymph nodes detected, compared with 20 out of 49 patients in the tracer-only group. For the secondary outcomes, the reported data shows that among the nodes examined in the combined group: 85 lymph nodes were picked up by both the green dye and the tracer; 15 were detected by the green dye only (tracer-negative); and 7 were detected by the tracer only (dye-negative). In terms of time, the reported data shows that surgery (from first cut to wound closure) took an average of 92.5 minutes in the combined group and 76 minutes in the tracer-only group. The time patients spent under anaesthetic averaged 171 minutes in the combined group and 152 minutes in the tracer-only group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02246621 · results posted 23 March 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT02246621) enrolled 493 people in total — 328 in the group receiving abemaciclib combined with a type of hormone-blocking drug called a nonsteroidal aromatase inhibitor (NSAI), and 165 in the group receiving a placebo (inactive dummy treatment) combined with the same NSAI. The trial was primarily measuring how long participants went without their disease getting worse (called "progression-free survival"), and also looked at a number of secondary measures including how many participants' tumours shrank or disappeared, how long those responses lasted, and how many participants had their disease kept under control. The reported data shows that, for the primary measure, the abemaciclib + NSAI group went a reported median (the middle value in the group) of 28.18 months before their disease progressed or they died, compared with 14.76 months in the placebo + NSAI group. For the secondary measures, the reported data shows that 49.7% of participants in the abemaciclib group had their tumour shrink significantly or disappear entirely, compared with 37% in the placebo group. Among those who did respond in this way, the response lasted a reported median of 27.39 months in the abemaciclib group versus 17.46 months in the placebo group. Disease control (meaning the tumour shrank, disappeared, or stayed stable) was reported in 88.7% of the abemaciclib group and 86.7% of the placebo group. A longer-term benefit measure — stable or shrinking disease lasting at least 6 months — was reported in 78.0% of the abemaciclib group and 71.5% of the placebo group. Overall survival data was listed as a secondary outcome but no figures were reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00053898 · results posted 12 March 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT00053898) involved 3,104 participants in total — 1,552 people in each of two groups. One group took tamoxifen (plus a placebo standing in for the other drug), and the other group took anastrozole (plus a placebo standing in for tamoxifen). The trial was measuring how many participants remained free from breast cancer events — such as the cancer returning in the same breast, the other breast, or spreading elsewhere — over a 10-year period. Nearly all participants completed the study, with only 14 and 13 people respectively not finishing in each group. The reported data shows that, at 10 years, 89.1% of participants in the tamoxifen group and 93.1% in the anastrozole group were recorded as free from any breast cancer event (the primary measure). For secondary measures, when looking only at invasive breast cancer events, 93.3% of the tamoxifen group and 96.4% of the anastrozole group were recorded as event-free. The reported data shows that 94.6% (tamoxifen) and 96.4% (anastrozole) were free from cancer returning in the same breast, while 94.7% (tamoxifen) and 97.0% (anastrozole) were free from cancer in the opposite breast. Rates of non-breast cancers were similar between groups — 91.5% versus 91.9% event-free. For bone fractures of the hip, spine, and wrist, 96.0% of the tamoxifen group and 95.3% of the anastrozole group were recorded as fracture-free. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00201760 · results posted 9 November 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 10 people with metastatic breast cancer (cancer that had spread beyond the breast), split evenly into two groups of 5. One group received a combination of three medicines — gemcitabine, cisplatin, and trastuzumab — while the other group received two medicines — gemcitabine and trastuzumab. All 10 participants completed the study. The trial was primarily looking at how many people were free from their cancer getting worse at 6 months after starting treatment. The reported data shows that, for the main measure (disease progression at 6 months), 1 out of 5 participants in the three-medicine group was free from disease progression at that point, compared to 0 out of 5 in the two-medicine group. For the secondary measure looking at response to treatment, the reported numbers were the same: 1 participant in the three-medicine group showed a response, and 0 in the two-medicine group. The trial also tracked serious side effects (graded as severe or very severe using a standard medical grading system). The reported data shows varying numbers of participants in each group experienced different types of serious side effects, with figures ranging from 0 to 2 patients across the different categories recorded, though the specific details of each side effect category were not fully labelled in the data provided. It is worth noting that with only 5 people in each group, this was a very small study, and the numbers reported are too limited to draw broad conclusions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00777101 · results posted 9 November 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 117 people in the neratinib group and 116 people in the lapatinib plus capecitabine (a combination treatment) group — 233 participants in total. The trial was studying women with a type of advanced breast cancer that tests positive for a protein called ErbB2 (also known as HER2). The main thing being measured was "progression-free survival" — that is, how many months passed before the cancer started growing again or a participant died. Several other things were also tracked, including how long participants lived overall, how many showed a measurable shrinkage in their tumours, and how often the cancer spread to the brain. The reported data shows that for the primary measure, progression-free survival, the neratinib group had a median (middle value) of 4.53 months, compared with 6.83 months in the lapatinib plus capecitabine group. For overall survival — the time from joining the trial until death from any cause — the reported median was 19.74 months for neratinib and 23.62 months for the combination group. When it came to the proportion of participants whose tumours shrank to a meaningful degree (called the objective response rate), the reported figures were 29.1% for neratinib and 40.5% for the combination. The clinical benefit rate — which also counted people whose disease stayed stable for at least 24 weeks — was reported as 44.4% for neratinib and 63.8% for the combination. Among those who did respond, the reported duration of that response was 12.48 months for neratinib and 7.98 months for the combination. Finally, the proportion of participants who had the cancer progress specifically in the brain was reported as 9.4% in the neratinib group and 12.9% in the combination group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00741260 · results posted 9 November 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 105 people across seven groups, each receiving different dose combinations of two medicines — neratinib (referred to as "N") and capecitabine (referred to as "C"). The trial had two main aims: first, to find the highest doses of each medicine that could be given together without too many serious side effects (called the "maximum tolerated dose"); and second, to observe how participants' tumours responded to treatment. Participants were grouped by the doses they received and by whether they had previously taken a related medicine called lapatinib. The reported data shows that, for finding the highest tolerable doses, the trial identified 240 mg per day for neratinib and 1,500 mg per square metre for capecitabine as the maximum tolerated doses when the two medicines were used together. When looking at which dose combinations caused serious side effects severe enough to require stopping or reducing the dose (called "dose-limiting toxicities"), the reported numbers were: zero participants in the 160 mg neratinib + 1,500 mg/m² capecitabine group; two in the 160 mg + 2,000 mg/m² group; two in the 200 mg + 2,000 mg/m² group; zero in the 240 mg + 1,500 mg/m² group; and two in the 240 mg + 2,000 mg/m² group. Zero dose-limiting toxicities were reported in both the lapatinib-naive and prior-lapatinib groups treated at the maximum tolerated dose. The reported data shows that, for the secondary measures looking at tumour response, the percentage of participants whose tumours shrank significantly (called the "overall response rate") was reported as approximately 57% for those who had previously taken lapatinib, and around 64% for those who had not. The "clinical benefit rate" — which also counts people whose disease remained stable for at least 24 weeks — was reported as approximately 71% for the prior-lapatinib group and around 73% for those new to lapatinib. Among participants who did show a response, the reported duration of that response was approximately 48 weeks for the prior-lapatinib group and around 46 weeks for the lapatinib-naive groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00878709 · results posted 9 October 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT00878709) enrolled 1,420 people in the neratinib group and 1,420 people in the placebo group — 2,840 participants in total. The trial was measuring how long people remained free of invasive breast cancer returning or spreading (called "invasive disease-free survival") over roughly two years, after they had already completed standard treatment for early-stage HER2-positive breast cancer. A placebo is a dummy treatment with no active ingredient, used so that neither group knows which one they are taking. The reported data shows that at the two-year mark, 4.7% of participants in the neratinib group had experienced a disease event (such as cancer returning or death from any cause), compared with 7.5% in the placebo group. Looked at another way, the estimated percentage of people who had not experienced such an event by two years was 94.2% in the neratinib group and 91.9% in the placebo group. For a broader measure that also included a non-invasive form of breast change (DCIS), the reported event rates were 4.7% (neratinib) versus 8.0% (placebo) at two years. For cancer spreading to distant parts of the body specifically, the reported event rates were 3.8% (neratinib) versus 5.4% (placebo). Overall survival figures — the percentage of people still alive — were also tracked at multiple time points; at the earliest reported point they were 99.64% (neratinib) and 99.43% (placebo), and at the latest reported point they were 89.06% (neratinib) and 88.65% (placebo). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02203565 · results posted 26 July 2017

According to the results reported on ClinicalTrials.gov, this trial involved 20 women who received a combination of radiation therapy and a wound-cleansing rinse called Dakin's solution as a form of supportive care. The trial was measuring how many of these women developed a more serious level of skin reaction — known as Grade 3 or 4 radiation dermatitis — on a scale that rates skin changes from 0 (no change) to 5 (bleeding, ulceration, or infection) during their course of radiation therapy. Of the 20 women who started the trial, 19 completed it and 1 did not. The reported data shows that 6 out of the 20 participants developed a Grade 3 or 4 skin reaction during their radiation treatment. Grade 3 is described on the scoring scale as dry peeling of the skin with a strong redness, while Grade 4 involves moist peeling of the skin. No other outcome measures were included in the submitted results data, so further details about other aspects of the experience were not reported here. It is worth noting that this trial had only one group — meaning there was no separate comparison group — so the reported number reflects only those who received the Dakin's solution and radiation therapy together. No comparison figures from a different treatment approach were reported in this data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00416715 · results posted 11 July 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 100 people, all of whom were being treated for early breast cancer with a medication called letrozole (a hormone-blocking treatment). Eighty-five participants completed the study, while 15 did not finish. The trial was looking at how many of these patients who had low vitamin D levels also experienced muscle pain, joint pain, and/or joint stiffness — and what happened to those symptoms after their vitamin D levels were topped up over one month. The reported data shows that, at the start of the study (before vitamin D top-up), 12 participants who had low vitamin D levels were experiencing muscle pain, joint pain, and/or joint stiffness. After one month of vitamin D replacement, the reported number of participants still experiencing those symptoms dropped to 1. The trial also measured the level of letrozole in participants' blood before and after vitamin D replacement. The reported data shows the average letrozole blood level was 85 micrograms per millilitre (a unit measuring how much of the drug is in the blood) at the start, and 70 micrograms per millilitre one month after vitamin D replacement. No further breakdown of these figures was reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00005879 · results posted 30 May 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 199 women in total — 101 in the placebo group and 98 in the arzoxifene group. The trial was measuring changes in breast cell appearance over 6 months, using samples taken from the breast. The main things being measured were a scoring system called the "Masood score" (a scale from 6 to 24, where a higher number means cells look more abnormal) and whether participants showed an improvement in the category of cell abnormality their cells were placed in. The reported data shows that, on average, the Masood score changed by minus 1.1 points in the placebo group and minus 0.8 points in the arzoxifene group — meaning both groups showed a small reduction (improvement) in the score over the 6 months. For the second primary measure — the number of participants whose cell abnormality category improved — the reported data shows 53 participants in the placebo group and 52 in the arzoxifene group showed improvement. A further breakdown also reported 31 participants in the placebo group and 30 in the arzoxifene group, though the specific detail distinguishing this second set of numbers was not fully described in the submitted data. No other outcome measure data was reported in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01958021 · results posted 12 May 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT01958021) enrolled 334 people in the ribociclib plus letrozole group and 334 people in the placebo plus letrozole group — 668 participants in total. The trial was measuring how long people lived without their cancer growing or spreading (called "progression-free survival"), as well as a range of secondary measures including how long people lived overall, how many people's tumours shrank, and how participants' daily functioning and quality of life changed over time. The reported data shows that for the main measure — time until cancer progression or death — the median figure for the placebo plus letrozole group was 14.7 months, while a median figure for the ribociclib plus letrozole group was not reported (listed as "NA" in the data, which can occur when more than half of participants in that group had not yet reached that point during follow-up). For overall survival, the reported median was 63.9 months in the ribociclib plus letrozole group and 51.4 months in the placebo plus letrozole group. When looking at tumour response, 40.7% of participants in the ribociclib plus letrozole group and 27.5% in the placebo plus letrozole group were reported to have their tumour shrink or disappear. A broader measure — including those whose disease stayed stable for at least 24 weeks — was reported at 79.6% and 72.8% respectively. The reported data also shows that for the time until participants' daily functioning noticeably declined (by at least one step on a standard scale), the ribociclib plus letrozole group had a reported median of 22.6 months, while a median for the placebo plus letrozole group was not reported. Similarly, the time until a meaningful drop in self-reported quality of life was recorded had a median of 19.3 months in the ribociclib plus letrozole group, while the figure for the placebo plus letrozole group was not reported in the data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02132949 · results posted 13 April 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 400 people with breast cancer — 199 in Cohort A and 201 in Cohort B. Both groups received a combination of chemotherapy drugs alongside pertuzumab and trastuzumab (two targeted medicines), but the specific chemotherapy drugs differed between the two groups. The trial was primarily focused on measuring heart-related outcomes: specifically, how often participants experienced serious heart failure symptoms, or a meaningful drop in how well their heart was pumping blood (measured as "left ventricular ejection fraction," or LVEF — essentially a measure of the heart's pumping strength). The reported data shows that during the pre-surgery treatment phase, serious heart failure symptoms (classified as moderate-to-severe, meaning significantly limiting daily activity) were recorded in 1.5% of Cohort A participants and 0% of Cohort B participants. A notable drop in heart pumping strength — defined as a fall of at least 10 percentage points to below 50% — was recorded in 6.5% of Cohort A and 2.0% of Cohort B participants overall during that same phase. During the post-surgery treatment phase, the reported data shows serious heart failure symptoms in 0% of Cohort A and 0.5% of Cohort B, while notable drops in heart pumping strength were recorded in 7.7% of Cohort A and 10.5% of Cohort B. During the follow-up period after all treatment had finished, serious heart failure symptoms were reported in 0% of Cohort A and 0.5% of Cohort B, and notable drops in heart pumping strength were recorded in 6.0% of Cohort A and 3.5% of Cohort B. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01007942 · results posted 5 April 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 284 people in the everolimus + vinorelbine + trastuzumab group and 285 people in the placebo + vinorelbine + trastuzumab group — a total of 569 participants. The trial was measuring how long people went without their cancer growing (called progression-free survival), how long people lived overall, how their tumours responded to treatment, and how their general health and quality of life changed over time. Very few participants — 3 in one group and 7 in the other — completed the study as planned, with the large majority leaving the study early for various reasons. The reported data shows that the main outcome — the median time before cancer progressed or death occurred — was 7.00 months in the everolimus group compared with 5.78 months in the placebo group. For overall survival (time from the start of the trial until death from any cause), the reported median figures were 23.46 months in the everolimus group and 24.08 months in the placebo group. The proportion of participants whose tumours shrank meaningfully (known as the overall response rate) was reported as 40.8% in the everolimus group and 37.2% in the placebo group. The "clinical benefit rate" — which includes people whose disease also stayed stable for at least 24 weeks — was reported as 59.2% versus 53.3% respectively. The reported data also shows that the median time before participants' general physical functioning (measured by a standard scale) worsened was 32.66 months in the everolimus group and 21.55 months in the placebo group. Quality-of-life scores, measured using a standard questionnaire, were reported across several areas; the time before a meaningful worsening in overall health and quality of life was recorded ranged from roughly 8 to 15 months depending on the specific measure and group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00075764 · results posted 4 April 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 694 people in total — 345 in one group who received a medicine called anastrozole on its own, and 349 in a second group who received anastrozole combined with another medicine called fulvestrant. The trial was designed to measure how long it took for tumours to start growing again (called "time to tumour progression"), as well as a number of other outcomes including how many participants experienced some level of disease control, how long participants lived overall, and how many experienced serious side effects linked to the study medicines. The reported data shows that, for the main measure — time to tumour progression — the anastrozole-only group had a median (that is, the middle value in the range of results) of 13.5 months, while the combination group had a median of 15.0 months. For the secondary measures, the reported data shows that around 70% of participants in the anastrozole-only group and 73% in the combination group experienced what the researchers called "clinical benefit" — meaning their disease either shrank or stayed stable for at least 24 weeks. For overall survival (how long participants lived from the start of the trial), the reported median was 41.3 months in the anastrozole-only group and 47.7 months in the combination group. Regarding serious side effects considered related to the study medicines, the reported data shows small numbers of participants in both groups experienced severe or life-threatening events across several categories, with individual counts generally ranging from zero to three participants per event type per group. No single event type appeared to affect large numbers of participants, though the data was not reported in a way that allows a full breakdown to be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00853996 · results posted 13 March 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 25 participants, all of whom completed the study — none dropped out. The trial was testing a drug called acolbifene hydrochloride in a prevention setting. It looked at whether the drug changed certain measurable features in breast tissue and the body over a six-month period. The main thing being measured was the proportion of breast cells showing a marker called Ki-67, which is used to indicate how actively cells are dividing or growing. A number of secondary measurements were also taken, including breast density on mammogram and levels of certain hormones in the blood. The reported data shows that, on average, the percentage of breast cells testing positive for Ki-67 changed by minus 3.0 percentage points over six months — meaning the proportion of positive cells was lower at the end of the study than at the start. For breast density (the proportion of the breast area appearing denser on a mammogram), the reported average change was minus 3.9 percentage points. The reported data also shows changes in hormone levels in the blood: estradiol (a form of oestrogen) changed by an average of 64.6 ng/ml, bioavailable estradiol (the portion of oestrogen not bound to a carrier protein in the blood) changed by 2.6 pM, and testosterone changed by 0.22 ng/ml. The trial also tracked hot flushes using a scoring system; the reported data lists counts of 6, 14, and 5 participants across different categories, though the labels for those specific categories were not included in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00615901 · results posted 3 March 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 38 participants, all placed in a single group called "Cohort A." Everyone in this group received a chemotherapy regimen known as CMF, given at 14-day intervals. The trial was looking at whether this treatment schedule was practical and manageable for patients — specifically, whether participants could complete all 8 planned cycles of treatment while keeping certain blood cell counts above a set level and without experiencing serious side effects (other than some that were expected, like hair loss, nausea/vomiting, and bone pain). The reported data shows that out of the 38 people who started the trial, 29 completed it, while 9 did not finish. The primary outcome — the number of participants who completed all 8 cycles of treatment — was reported as 29. No further breakdown was provided in the submitted results about why the remaining 9 participants did not complete the trial, and additional detail on the number of days taken to complete all 8 cycles was not reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01262027 · results posted 2 February 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 22 people, all of whom received a drug called dovitinib. The trial was measuring how their tumours responded to the treatment over the first six months, looking for signs such as the tumour disappearing completely (called a complete response), shrinking by at least half (partial response), or staying stable and not growing (stable disease). Of the 22 who started, 17 completed the study and 5 did not. The reported data shows that, out of the 22 participants, zero experienced a complete response, zero experienced a partial response, and one participant experienced stable disease within the first six months. The primary goal of the trial — seeing an overall response in participants — was therefore met by only one person according to the figures submitted. For the secondary outcome looking at side effects, the reported data shows that 5 participants experienced the most frequently reported treatment-related unwanted effects, and 3 participants experienced a second commonly reported type. The trial's results submission notes that full details of all side effects can be found in a separate adverse events section of the ClinicalTrials.gov record, so the data available here covers only a summary. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01301729 · results posted 29 December 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 32 people, all of whom received the medicine trastuzumab. Of those, 28 completed the study and 4 did not finish. The trial was looking at how long participants went without their disease getting worse (called "progression-free survival"), as well as a number of other measures including how many people's tumours shrank, how long those responses lasted, how long participants lived overall, and how often unwanted medical events occurred. The reported data shows that, on average, participants went approximately 9.9 months before their disease progressed or they passed away — this is the progression-free survival figure. When looking at tumour response, the reported data shows that 81.3% of participants had their tumour either completely disappear or shrink by at least 30%. For those who did respond in this way, the reported data shows that the response lasted a median of 9.8 months. For overall survival — meaning how long participants lived from the time they joined the trial — the data was not reported (listed as "not available"). The reported data also shows that 93.8% of participants experienced at least one adverse event, meaning an unwanted medical occurrence of any kind, during the study. Results for a planned analysis of biological markers (substances in blood or tumour tissue that might indicate who responds to treatment) were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01075100 · results posted 7 December 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 103 people with advanced breast cancer — 49 in a group with "triple negative" breast cancer (a type that does not respond to certain hormone-based treatments) and 54 in a group with "hormone receptor positive" breast cancer. The trial was measuring how their tumours responded to treatment, using standard imaging-based criteria to track whether tumours shrank, stayed stable, or grew. Almost all participants did not complete the study (only one person in the hormone receptor positive group was recorded as completing it), which is common in trials where participants leave for various reasons such as disease progression. The reported data shows that the main thing being measured — the proportion of participants whose tumours shrank significantly (either disappearing completely or reducing by 30% or more) — was 30.4% in the triple negative group and 34% in the hormone receptor positive group. A related measure called "clinical benefit rate" — which also counted people whose disease stayed stable for at least six months — was reported as 41.3% in the triple negative group and 56.6% in the hormone receptor positive group. The reported data shows that the median time until the disease started progressing (getting worse) was 7.6 months in both groups. For overall survival — how long participants lived from the start of the trial — the reported figures were 12.5 months for the triple negative group and 17.9 months for the hormone receptor positive group. Among those whose tumours did respond, the response was first recorded at around 1.3 months (triple negative) and 1.6 months (hormone receptor positive), and lasted approximately 6.7 months and 5.9 months respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02748213 · results posted 22 November 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 113 people in one group and 112 in another — a total of 225 participants. One group received a combination of three medicines (Herceptin, Taxotere, and Xeloda), while the other received two medicines (Herceptin and Taxotere). The trial's main goal was to measure how many participants in each group had their tumours shrink or disappear during treatment, based on a standard set of measuring rules called RECIST. The reported data shows that for the primary (main) measurement — the proportion of people whose tumours either disappeared completely or shrank meaningfully — 70.5% of participants in the three-medicine group and 72.7% in the two-medicine group met that threshold. For the secondary (additional) measurements, the reported figures were as follows. The proportion of participants whose disease got worse or who died was 67.9% in the three-medicine group and 77.3% in the two-medicine group. The median time (the middle point in the spread of times) before disease worsened or death occurred was reported as 17.9 months for the three-medicine group and 12.8 months for the two-medicine group. The proportion who died from any cause was 35.7% versus 41.8%. The median overall survival (time from the start of treatment until death for any reason) was reported as 43.5 months and 47.3 months respectively. Finally, the median length of time that a response (tumour shrinkage or disappearance) lasted was reported as 15.9 months in the three-medicine group and 13.4 months in the two-medicine group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02806544 · results posted 17 November 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 35 participants, all of whom received tamoxifen (a hormone-based treatment) before surgery for breast cancer. The main goal of the study was to find out whether it was practically possible to recruit enough participants and have at least half of them complete the trial — a question of "feasibility" rather than testing whether the treatment worked. Of the 35 who started, 31 completed the study, and 4 did not. The reported data shows several things that were tracked along the way. Researchers measured a protein called Ki67 — a marker found in tumour tissue that gives an indication of how quickly cancer cells are dividing — in participants who had a biopsy taken after 4 to 6 weeks on tamoxifen. Out of those who had this biopsy, 15 participants showed a low Ki67 level (10% or below), which the trial defined as a "response." Of those considered responders, 13 went on to have surgery, and none of those 13 had breast-conserving surgery (such as a lumpectomy) — all required a mastectomy. When doctors examined tumours by touch (physical examination) after 4 months of treatment, 13 participants showed either a complete or partial reduction in tumour size. Only 1 participant had no detectable tumour remaining in either the breast or the lymph nodes when the surgical tissue was examined in the laboratory. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00977379 · results posted 15 November 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT00977379) enrolled 24 people in total — 12 in each group. All participants had cancer that had spread to the brain (known as brain metastases). One group received whole-brain radiation therapy (WBRT) followed by standard care, while the other group received WBRT combined with a medicine called capecitabine, followed by capecitabine on its own as ongoing treatment. The trial was primarily measuring how many participants showed a meaningful shrinkage or disappearance of their brain tumours on MRI scans. It is worth noting that no participants were recorded as having "completed" the study in the formal sense, and all 24 were listed as "not completed," which the reported data does not explain further. The reported data shows that, based on independent expert review of MRI scans, 25% of participants in the radiation-only group and 36.4% in the radiation-plus-capecitabine group showed the best overall brain tumour response (meaning their tumours either disappeared or shrank by at least 30%). When the treating doctors — rather than independent experts — reviewed the scans, those figures were higher: 50% in the radiation-only group and 54.5% in the radiation-plus-capecitabine group. A separate measure called "clinical benefit" — which counted participants whose tumours disappeared, shrank, or simply stayed stable — was reported as 83.3% in the radiation-only group and 72.7% in the capecitabine group. One secondary outcome measuring tumour response using a three-dimensional MRI method was not reported in the data submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00021255 · results posted 15 November 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled over 3,200 people across three treatment groups. All participants had HER2-positive breast cancer (a type where a particular protein plays a role in the cancer's growth). The trial compared three different chemotherapy combinations: one without a targeted therapy called Herceptin (also known as trastuzumab), and two that included Herceptin alongside different chemotherapy drugs. The main thing researchers were tracking was "disease-free survival" — meaning how many participants went five years without their cancer returning, spreading, or a new cancer appearing, and without dying. The reported data shows that at the five-year mark, approximately 75.5% of participants in the chemotherapy-only group (AC followed by Docetaxel) were disease-free, compared to around 83.2% in the group that received AC followed by Docetaxel plus Herceptin, and approximately 81.0% in the group that received Docetaxel, Carboplatin, and Herceptin together. The trial also tracked results at ten years. At that point, the reported disease-free figures were roughly 67.2%, 73.4%, and 72.3% for the three groups respectively. For overall survival at ten years — meaning the percentage of participants still alive regardless of whether their cancer had returned — the reported figures were approximately 78.9%, 86.0%, and 83.4% across the three groups in the same order. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00493649 · results posted 3 November 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 493 people with a type of early-stage breast cancer that tests positive for a protein called HER2. All participants received the same treatment combination, referred to as TC+H (a chemotherapy regimen combined with a targeted therapy). The trial was particularly interested in whether a gene marker called TOP2A — which can be either amplified (present in higher-than-normal amounts) or non-amplified (present at normal levels) — made a difference to outcomes. A secondary marker called cMYC was also looked at. Of the 493 people who started the trial, 411 completed it, and 82 did not complete it. The reported data shows that the main thing being measured was "disease-free survival" at two years — that is, the probability that a participant had not had their cancer return and had not died within two years. For participants whose tumours had TOP2A amplification, the reported two-year disease-free survival probability was 0.978 (roughly 97.8 in every 100 people). For those without TOP2A amplification, it was 0.979 (roughly 97.9 in every 100). For overall survival at two years (meaning still alive, regardless of whether cancer had returned), the reported probability was 0.995 for the TOP2A-amplified group and 0.988 for the TOP2A-non-amplified group. The reported data also shows results broken down by the cMYC marker. For participants with cMYC amplification, the two-year disease-free survival probability was reported as 0.968, compared with 0.981 for those without cMYC amplification. Two-year overall survival probabilities for the cMYC groups were reported as 0.990 and 0.991 respectively — very similar figures between the two groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01167192 · results posted 28 October 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 10 people who received a combination of chemotherapy (either cisplatin or carboplatin) together with radiation therapy before surgery — an approach sometimes called neoadjuvant chemoradiation. The trial was primarily measuring how many participants' tumours responded to this treatment (either disappearing completely or shrinking significantly), and whether there was a link between tumour response and certain biological features related to DNA repair. Six of the 10 participants completed the study, and four did not. The reported data shows that, of the participants assessed for tumour response, 3 achieved a complete response (meaning all detectable signs of tumour disappeared) and 3 achieved a partial response (meaning the tumour shrank by at least 30%). For the secondary outcomes, the reported data shows the median time to disease progression — that is, the midpoint at which half the participants had their disease worsen or spread — was 6.5 months. One participant was reported to have experienced surgical complications. The overall survival rate was reported as 75% of participants. Two other planned measurements — the link between DNA repair and tumour response, and the effect of treatment on cancer cells detected in the bone marrow — had no data reported for them. It is worth noting that this was a very small trial of only 10 people, and the reported data for some outcomes was not provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01298362 · results posted 20 September 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 290 women with breast cancer across two groups: 124 in the "CT Cohort" (who received chemotherapy before starting a type of hormone-blocking medication called an aromatase inhibitor, or AI) and 166 in the "HT Cohort" (who went straight onto AI therapy without prior chemotherapy, acting as a comparison group). Of those who started, 86 and 123 participants respectively completed the study. The trial was measuring changes in bone density — the strength and thickness of bones — at the lower spine and hip over 12 months of AI therapy, using a type of bone scan called a DEXA scan. The reported data shows that in the CT Cohort, lumbar spine (lower back) bone density changed by an average of −0.72% from before chemotherapy to after 12 months of AI therapy, and −0.19% from before chemotherapy to when chemotherapy finished. Hip bone density in the same group showed a reported change of +0.83% over the 12-month AI period. For the HT Cohort (the comparison group who had no chemotherapy), the reported data shows lumbar spine bone density changed by +1.51% and hip bone density changed by −0.94% over 12 months of AI therapy. These figures represent average percentage changes across each group — meaning some individuals in the groups would have had higher or lower changes than these averages. The reported data also shows that the number of bone fractures recorded during the study was zero in both groups. It is worth noting that results for some measurements were only reported for one group rather than both, and no explanation for this was included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01777945 · results posted 19 August 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 46 people, all of whom received a combination of two medicines — capecitabine and docetaxel. Forty-five of the 46 participants were considered evaluable (meaning their results could be fully assessed). The trial was measuring how long participants went without their disease getting worse, how long they stayed on the treatment, and how their tumours responded to the medicines. The reported data shows that the main outcome — called progression-free survival, meaning the time from joining the trial until the disease progressed or the participant died from any cause — was reported as approximately 9.89 months on average. For the secondary outcomes, the reported data shows that participants stayed on the treatment combination for an average of about 4.64 months before stopping one or both medicines for any reason. In terms of tumour response, approximately 28.9% of participants were reported to have had their tumour shrink (either fully or partially). A broader measure called the "clinical benefit rate" — which includes both tumour shrinkage and stable disease (where the tumour did not grow or shrink significantly) — was reported at 73.3% of participants. On average, participants completed around 6.24 treatment cycles of capecitabine, and dose adjustments to capecitabine were recorded for 44.4% of doses administered. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00951665 · results posted 24 June 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled participants across two phases. In the first phase (Phase Ib), 63 people were enrolled across four different treatment regimens (29, 10, 21, and 3 participants respectively), testing different dosing schedules of a combination of drugs called T-DM1 and paclitaxel, with or without a third drug called pertuzumab. The second phase (Phase IIa) enrolled 22 people in each of two groups (44 total), with one group receiving T-DM1 and paclitaxel, and the other receiving all three drugs together. The trial was primarily measuring how participants responded to the drug combinations in terms of side effects and tolerability, and what the highest manageable doses were. The reported data shows that in Phase Ib, every participant who started treatment experienced at least one adverse event (an untoward medical occurrence during the trial). Serious adverse events were reported in 7, 5, 7, and 2 participants across the four Phase Ib regimens, and in 6 participants in each of the two Phase IIa groups. Notably, no participants in Phase Ib experienced what the trial defined as a "dose-limiting toxicity" — meaning no one in the first phase hit the threshold of side effects that would require stopping dose increases. The reported highest manageable dose of T-DM1 was 3.6 mg/kg for two regimens and 2.4 mg/kg for the other two, while the highest manageable dose of paclitaxel was 80 mg/m² across all four regimens. In Phase IIa, 11 out of 22 participants in each group received 12 or more doses of paclitaxel as planned. The reported data also shows that dose adjustments (delays or reductions) due to side effects were common across all groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00072293 · results posted 18 May 2016

According to the results reported on ClinicalTrials.gov, this trial involved 934 participants in total — 465 in one group who received axillary dissection (a surgical procedure to remove lymph nodes from the armpit) and 469 in a group who did not receive axillary dissection. The trial was measuring how participants fared over five years, specifically looking at "disease-free survival" (meaning the person was alive with no sign of cancer returning or a new cancer developing) and overall survival (meaning simply still being alive, regardless of cancer status). The reported data shows that at the five-year mark, an estimated 84.4% of participants in the axillary dissection group were alive and disease-free, compared with 87.8% in the no axillary dissection group. For overall survival at five years, the reported figures were very close: 97.6% in the axillary dissection group and 97.5% in the no axillary dissection group. The trial also tracked where cancer returned in participants who experienced a recurrence. The reported data shows various sites of recurrence were recorded across both groups, with numbers of participants ranging from 1 to 34 depending on the site and group, though a full breakdown of which numbers correspond to which specific recurrence sites was not clearly labelled in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01215123 · results posted 22 February 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 28 participants, all of whom completed the study — none dropped out. All participants received a medicine called bevacizumab. The trial was looking at two main things: how long it took for participants' disease to progress (get worse or spread), and how many treatment cycles participants received. The reported data shows that, on average, it took approximately 15.3 months from the start of treatment before participants' disease showed signs of progression. Disease progression was measured using a standard set of criteria that looks at changes in the size of tumours or the appearance of new ones. For the second measure, the reported data shows that participants received an average of 6 cycles of bevacizumab treatment during the course of the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00428922 · results posted 12 February 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 26 participants, all of whom completed the study. Every participant received the same combination of three medicines: trastuzumab, bevacizumab, and docetaxel. The trial was primarily measuring how long participants went without their disease getting worse (called "progression-free survival"), and it also looked at several other things, including certain cells found in the blood that researchers hoped might help predict how patients would respond to treatment. The reported data shows that the median time before disease progression was 14.3 months. In simple terms, this means that, at the midpoint of the group, half the participants had gone at least 14.3 months without their disease worsening. For one of the secondary measures, 7 out of 26 participants had detectable circulating tumour cells (special cells that had shed from tumours and were found in the bloodstream) at the point they were tested. The reported data also shows that 69% of participants experienced what the researchers called "clinical benefit" — meaning their disease either shrank, disappeared, or stayed stable for at least 24 weeks. For the fourth measure — a different type of blood cell called circulating endothelial cells — no results data was reported on ClinicalTrials.gov. It is worth noting that the trial originally aimed to enrol 39 participants but only 26 were enrolled, which the researchers had planned to account for in how they judged the results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01325428 · results posted 11 February 2016

According to the results reported on ClinicalTrials.gov, this trial ran in two parts and looked at how participants' tumours responded to treatment. In Part A, 26 people started taking afatinib (a tablet taken once a day) on its own, and 10 of them went on to Part B. In Part B, those 10 people received afatinib combined with another medicine called vinorelbine. The trial was mainly measuring something called "clinical benefit" — which the researchers defined as a tumour either shrinking (a partial or complete response) or staying stable for at least six months, based on a standard system for measuring tumour size called RECIST 1.1. The reported data shows that in Part A, 35% of participants were recorded as achieving clinical benefit on afatinib alone. In Part B, 20% of participants were recorded as achieving clinical benefit on the combination of afatinib and vinorelbine. For a secondary measure — looking only at confirmed tumour shrinkage (partial or complete response) — the reported figures were 31% in Part A and 10% in Part B. When unconfirmed responses were also included, the reported figures were 42% in Part A and 30% in Part B. Because Part B involved only 10 people, these percentages represent very small numbers of individuals. It is worth noting that this was a small trial with a limited number of participants, particularly in Part B, so the reported percentages each represent only a handful of people. The reported data shows what was observed and measured during the trial; it does not tell us how these results compare to other treatments or what they would mean for any individual person. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00333775 · results posted 27 January 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 736 people across three groups, all of whom had a form of cancer being treated with a chemotherapy drug called docetaxel. One group (241 people) received docetaxel plus a placebo (an inactive substance), a second group (248 people) received docetaxel plus a lower dose of a drug called bevacizumab, and a third group (247 people) received docetaxel plus a higher dose of bevacizumab. The trial's main goal was to measure "progression-free survival" — that is, how long participants went before their disease got worse or they died. The reported data shows that, for the primary measure, the median time before disease worsening or death was 8.0 months in the placebo group, 8.7 months in the lower-dose bevacizumab group, and 8.8 months in the higher-dose bevacizumab group. For the secondary measures, the percentage of participants whose tumours either disappeared completely or shrank significantly was reported as 44.5% in the placebo group, 55.2% in the lower-dose group, and 63.1% in the higher-dose group. Among those who did respond, the reported duration of that response was 6.4, 7.2, and 7.0 months respectively across the three groups. The time until treatment stopped working or was discontinued for any reason was reported as 6.1, 7.0, and 7.7 months across the three groups. The reported data shows that overall survival figures — meaning how long participants lived in total — were not reported in the submitted results for any of the three groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01752907 · results posted 11 January 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 304 people in total — 151 in a group that watched a general education DVD and 153 in a group that watched a DVD specifically about bone pain. All participants were receiving a medicine called pegfilgrastim (a drug commonly given alongside cancer chemotherapy). The trial was measuring whether the type of educational DVD people watched made a difference to the level of bone pain they reported, using a daily survey scored from 0 (no pain) to 10 (worst possible pain), filled in over 5 days after each injection. The reported data shows that for the main measure — the highest bone pain score reported during the first treatment cycle — the general education DVD group recorded an average peak score of 3.2 out of 10, while the bone pain education DVD group recorded 3.5 out of 10. Across all treatment cycles combined, the reported data shows peak scores ranged from roughly 2.4 to 4.1 in the general education group and 2.5 to 4.6 in the bone pain education group. Average (mean) pain scores across all cycles were lower, sitting between approximately 1.3 and 1.6 in the general education group and 1.4 to 1.8 in the bone pain education group. When looking at how many participants experienced any level of bone pain recorded through standard medical reporting, the figures across cycles ranged from about 37% to 58% in the general education group and 35% to 56% in the bone pain education group. For more severe bone pain (graded as serious or worse), the reported figures were generally low, ranging from 0% to 4.7% in the general education group and 2.1% to 6.6% in the bone pain education group across the different cycles. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00022516 · results posted 11 December 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,086 people with breast cancer — 542 in a group that received no additional chemotherapy maintenance (called "No-CM") and 544 in a group that received chemotherapy maintenance (called "CM-Maintenance"). The trial was measuring how participants fared over five years across several milestones, including whether their cancer returned, whether they developed a new cancer, and whether they were still alive. It is worth noting that 230 people in the CM-Maintenance group did not complete the study, compared to only 3 in the No-CM group. The reported data shows that the primary measure — the estimated percentage of participants who were alive and free of disease at five years — was 74.7% in the No-CM group and 78.1% in the CM-Maintenance group. For overall survival (the percentage still alive at five years regardless of disease status), the reported figures were 85.0% for No-CM and 85% for CM-Maintenance. The reported data also shows that for the "distant recurrence-free interval" (meaning cancer had not spread to other parts of the body), the five-year estimates were 83.5% for No-CM and 85.5% for CM-Maintenance. Finally, for the "breast cancer-free interval" (meaning no breast cancer had returned or appeared in the other breast), the figures were 77.3% for No-CM and 81.0% for CM-Maintenance. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00852930 · results posted 2 November 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 50 people across three groups to compare different treatments for arm lymphoedema (a build-up of fluid that can cause swelling, often after breast cancer treatment). Sixteen people were assigned to laser therapy alone, 17 to manual lymphatic drainage (MLD, a type of gentle massage) alone, and 17 to a combination of both. Most participants finished the study — 15, 16, and 15 respectively completed it, with a small number leaving each group before the end. The trial measured two main things: fluid levels in the arm using a device called bioimpedance (which produces a score called LDex — a higher number suggests more fluid build-up) and the percentage difference in arm volume between the affected and unaffected arm. The reported data shows that at the end of the study, the LDex scores were 28.0 for the laser-only group, 17.8 for the MLD-only group, and 22.2 for the combined group. For arm volume percentage difference, the reported figures were 15.0% for laser only, 6.8% for MLD only, and 13.4% for the combined group. The trial also measured two secondary outcomes: the number of symptoms participants reported from a standard checklist (12 for laser only, 12.5 for MLD only, and 14 for the combined group), and quality of life using a standard questionnaire scored out of 148, where higher means better (113.5 for laser only, 116.25 for MLD only, and 110 for the combined group). The reported data does not include details about what scores looked like before treatment began, so direct before-and-after comparisons cannot be made from this summary. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00248170 · results posted 9 October 2015

According to the results reported on ClinicalTrials.gov, this trial compared two medicines — letrozole and anastrozole — in women with breast cancer. Both medicines belong to a class sometimes used after surgery to reduce the chance of cancer returning. A total of 2,078 people were assigned to the letrozole group and 2,094 to the anastrozole group when the study began. By the end of the study period, 1,317 people in the letrozole group and 1,286 in the anastrozole group had completed the trial, with the remainder not completing it for various reasons. The trial was measuring things like how long participants went without signs of the disease returning, how long they survived overall, and whether there were any changes in blood cholesterol levels. The reported data shows that for the main outcome — how long people remained free of the disease — the results were listed as "NA" (not available) for both groups. The same applies to several other outcomes that were tracked, including overall survival, time for the cancer to spread to other parts of the body, cancer appearing in the opposite breast, and a combined measure of distant disease and survival. This means that specific time-based figures for these outcomes were not reported in the data submitted to ClinicalTrials.gov. The one area where numbers were reported was cholesterol levels in the blood, measured at several points over time. The reported data shows total cholesterol (adjusted average figures) for the letrozole group ranged from around 5.4 to 5.6 mg/dL across the various time points, and for the anastrozole group from around 5.4 to 5.6 mg/dL as well — the figures were similar between the two groups at each measurement point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00513292 · results posted 29 September 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 280 people with HER2-positive breast cancer — 138 in one group and 142 in the other. Both groups received the same chemotherapy medicines (FEC-75, paclitaxel, and trastuzumab), but in a different order. The trial's main goal was to measure how many people in each group had no detectable invasive cancer remaining in the breast when they had surgery after completing chemotherapy — a result doctors call a "pathological complete response," or pCR. The reported data shows that in the group who received FEC-75 first and then paclitaxel/trastuzumab, 56.5% of participants had no invasive cancer remaining in the breast at surgery. In the group who received paclitaxel/trastuzumab first and then trastuzumab/FEC-75, that figure was 54.2%. For a secondary measure — which also checked whether the lymph nodes under the arm were clear of invasive cancer — the reported figures were 48.3% and 46.7% respectively. The trial also tracked changes in heart pumping function (measured by scans) at 12 and 24 weeks into treatment. The reported data shows small changes in these heart function scores across both groups at both time points, though the full breakdown of those figures is complex and was not reported in a single summary number. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01234337 · results posted 3 September 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 266 people in the sorafenib plus capecitabine group and 271 people in the placebo plus capecitabine group — a total of 537 participants. The trial was comparing these two treatment combinations in people with cancer, looking mainly at how long it took for the disease to get worse (called "progression-free survival"), as well as a number of other measurements including how long people lived overall, how often tumours shrank, and how long any shrinkage lasted. The reported data shows that the median time before the disease got worse or participants died was 166 days for the sorafenib plus capecitabine group and 165 days for the placebo plus capecitabine group. For overall survival (how long participants lived from the start of the trial), the reported median figures were 575 days in the sorafenib group and 616 days in the placebo group. When looking at how many participants' tumours shrank meaningfully, the reported data shows 13.5% in the sorafenib group and 15.5% in the placebo group. Disease control — meaning tumours that either shrank or stayed stable — was reported in 60.5% of the sorafenib group and 58.3% of the placebo group. Among those whose tumours did shrink, the reported median duration of that response was 313 days in the sorafenib group and 290 days in the placebo group. It is worth noting that no participants were recorded as having "completed" the trial in the conventional sense; the data shows all participants were recorded under "not completed." These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02491892 · results posted 25 August 2015

According to the results reported on ClinicalTrials.gov, this trial (NCT02491892) looked at two different doses of a medicine called pertuzumab in people with cancer. One group of 41 participants received a lower dose (420 mg) and another group of 38 participants received a higher dose (1,050 mg). The trial was mainly measuring how many participants had their tumours shrink or disappear — either completely or by at least 30% — based on scans assessed using a standard set of criteria for measuring tumour size changes. The reported data shows that in the lower-dose group, 4.9% of participants (roughly 2 out of 41 people) had their tumours shrink enough to count as a meaningful response. In the higher-dose group, 0% of participants met that threshold. No participants in either group had their tumours disappear completely. For the lower-dose group, the reported data shows that the time from starting treatment to first recorded shrinkage was around 12.1 weeks, and that response lasted around 24.6 weeks on average. These time-to-response and duration figures were not reported for the higher-dose group, as no participants in that group met the response criteria. The reported data also shows that 38 out of 41 participants in the lower-dose group and 36 out of 38 in the higher-dose group experienced their disease progressing or died during the study period. It is worth noting that the reported data shows zero participants were recorded as having formally "completed" the trial in either group — the data does not explain this further, so the reasons were not reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01011946 · results posted 9 July 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 36 people, all of whom underwent a type of imaging scan called Positron Emission Mammography (PEM). This is a specialised breast scanning technique that uses a mildly radioactive sugar (FDG) to produce images. The trial was measuring how well this scan could identify whether breast cancer had spread to the lymph nodes under the arm — a key question in understanding how far a cancer may have progressed. Of the 36 people who started, 33 completed the study and 3 did not. The reported data shows two key figures for the PEM scan's performance in detecting cancerous lymph nodes. The first figure — called "sensitivity," meaning the percentage of time the scan correctly identified lymph nodes that did have cancer — was reported as 83.3%. The second figure — called "specificity," meaning the percentage of time the scan correctly identified lymph nodes that did not have cancer — was reported as 52.0%. These results were compared against physical tissue samples taken from the lymph nodes and examined under a microscope, which served as the reference standard. No other outcome measures were reported in the submitted data. It is worth noting that this was a small study involving only 36 participants, and the reported data does not include figures for all measures that might be needed to fully understand these results. Any figures not included in the submitted data were not reported, rather than estimated here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01250379 · results posted 30 June 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 494 people with breast cancer — 247 in each group. One group received chemotherapy alone, and the other received chemotherapy plus a medicine called bevacizumab. The trial was mainly looking at how long participants went without their cancer getting worse during their second round of treatment (called "progression-free survival"), as well as how their tumours responded to treatment. The reported data shows that, for the main measure, the median time before the cancer got worse or a person died was 4.2 months in the chemotherapy-only group and 6.3 months in the chemotherapy-plus-bevacizumab group. (Median means half of the participants reached that point before that time, and half after.) Additionally, 88.7% of the chemotherapy-only group and 93.9% of the chemotherapy-plus-bevacizumab group experienced a progression or death event during the second-line treatment period. For tumour response, 16.8% of participants in the chemotherapy-only group and 20.9% in the combination group had their tumour shrink significantly (a complete or partial response). The reported data also shows that among those whose tumours did shrink, the median time they stayed shrunken was 10.6 months in the chemotherapy-only group and 8.3 months in the combination group. Several other breakdowns by patient characteristics were also reported, with median progression-free survival figures varying across subgroups in both arms. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00448591 · results posted 25 May 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 2,296 participants, all of whom received the medicine bevacizumab. The trial was an observational study — meaning it watched what happened in real-world clinical practice rather than comparing bevacizumab against a different treatment. The main thing the trial set out to measure was how often participants experienced unwanted medical events (called adverse events) while receiving bevacizumab. It also tracked how the disease changed over time and how long participants lived. The reported data shows that, for the primary (main) outcome, 95.4% of participants had some kind of adverse event considered related to bevacizumab, and 57.6% had a serious adverse event (one serious enough to require hospitalisation or similar). Additionally, 64.2% experienced what are called "adverse events of special interest" — particular events the researchers were specifically watching for — and 29.7% experienced these at a more severe level. The reported data also shows that 7.6% of participants died during the study period, and 53.1% had deaths recorded overall. For the secondary (additional) outcomes, 72.44% of participants were reported to have had their disease get worse (progress) during the study. The median time until disease progression — meaning the point at which half of participants had experienced worsening — was reported as 9.7 months. The median overall survival (the point at which half of participants had died) was reported as 25.2 months. Regarding how the disease responded to treatment, the reported data shows 9.0% of participants had a complete response, 45.1% had a partial response, 32.4% had stable disease, 9.1% had progressive disease, 0.1% had an unknown response, and 4.2% were not evaluable. Notably, the data shows zero participants were recorded as having "completed" the study, though the reasons for this are not explained in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00201851 · results posted 29 April 2015

According to the results reported on ClinicalTrials.gov, this trial involved 740 people in total across three groups. Two of the groups were randomly assigned — 252 people to "Scheduled Surgery" (Group A) and 257 people to "Immediate Surgery" (Group B). A third, non-randomised group of 231 people also received immediate surgery (Group C). The trial was measuring what is called "disease-free survival" over five years — that is, the percentage of participants who were alive and had not had their condition return or worsen five years after treatment. The reported data shows the following five-year disease-free survival figures: in Group A (Scheduled Surgery), 64% of participants were disease-free at five years; in Group B (Immediate Surgery, randomised), 71% of participants were disease-free at five years; and in Group C (Immediate Surgery, non-randomised), 70% of participants were disease-free at five years. No other outcome measures were included in the submitted results data. It is worth noting that the non-randomised group cannot be directly compared to the two randomised groups in the same way, as the people in that group were not assigned by chance. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00843167 · results posted 24 February 2015

According to the results reported on ClinicalTrials.gov, this trial (NCT00843167) involved 54 people in total — 27 who took a sulforaphane supplement (a natural compound found in broccoli and related vegetables) and 27 who took a placebo (a dummy pill with no active ingredient). The trial was looking at biological changes in the body that might be relevant to breast cancer research, specifically measuring: a chemical called isothiocyanate in urine (as a sign the supplement was being absorbed), a protein called Ki-67 in breast tissue (a marker of how actively cells are dividing), and an enzyme called HDAC in blood cells (which plays a role in how genes are switched on or off). By the end of the treatment period, 24 people in the supplement group and 19 in the placebo group had completed that phase. The reported data shows the following numbers for each measurement. For urine isothiocyanate levels, the sulforaphane group showed an average change of +1.00 units (µM/mM creatinine), while the placebo group showed a change of −0.05 units — meaning the supplement group had a higher recorded increase in this urinary marker. For HDAC enzyme activity in blood cells, the sulforaphane group showed an average change of −80.39 units, compared to +27.52 units in the placebo group — meaning the sulforaphane group had a recorded decrease and the placebo group a recorded increase in this enzyme's activity. For the Ki-67 protein (measured on a scoring scale from 0 to 300, converted here using a mathematical transformation called a log scale), changes were reported separately across three tissue types — benign (non-cancerous), DCIS (an early-stage breast condition), and invasive ductal carcinoma (a type of breast cancer). The reported changes varied across these tissue types; however, because the data as submitted does not clearly separate which numbers belong to the sulforaphane versus placebo group for Ki-67, those specific figures cannot be described with confidence here. The reported data also shows that for the secondary measure of whether participants took their pills as directed (at least 80% of doses), 19 out of the sulforaphane group and 16 out of the other group met this threshold. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00591851 · results posted 1 December 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 70 participants, all of whom received the same treatment sequence: a chemotherapy combination called AC (doxorubicin and cyclophosphamide) followed by paclitaxel (another chemotherapy) given together with trastuzumab (a targeted therapy). Sixty-four participants completed the study, while six did not finish. The trial was focused on measuring heart safety — specifically, how well the heart was pumping blood throughout the course of treatment. The reported data shows that heart function was tracked using a type of heart scan called a MUGA scan, which measures what is known as LVEF — essentially, the percentage of blood the heart pumps out with each beat. According to the results reported on ClinicalTrials.gov, the LVEF measurements recorded at five time points during the study were 68%, 67%, 66%, 65%, and 66%. The data does not include labels specifying exactly when each of these measurements was taken, so the precise timing of each reading was not reported in a way that can be described here. The reported data shows only this single set of heart function measurements — no other outcome measures, such as tumour response or survival figures, appear to have been submitted to ClinicalTrials.gov for this trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00475670 · results posted 15 September 2014

According to the results reported on ClinicalTrials.gov, this trial (NCT00475670) enrolled 44 participants in total — 3 in a trastuzumab monotherapy group and 41 in a group receiving trastuzumab combined with a taxane (a type of chemotherapy). The trial was measuring how tumours responded to these treatments in people with a type of breast cancer, using standard criteria (called RECIST) to assess whether tumours shrank, disappeared, or grew. The reported data shows that none of the participants were recorded as having "completed" the study in the usual sense, and all were listed under "not completed," though specific reasons were not detailed in the data provided. The reported data shows results only for the trastuzumab-plus-taxane group — no outcome numbers were reported for the trastuzumab monotherapy group. For the combination group, 61% of participants were reported to have had either a complete response (tumour disappearing entirely) or a partial response (tumour shrinking by at least 30%). Among those who had such a response, 88% were later reported to have experienced their disease progressing or to have died. The reported median duration of response — meaning the midpoint of how long responses lasted — was 8 months. Similarly, the time until disease progression or death (called progression-free survival) had a reported median of 8 months, with about 88% of participants eventually experiencing progression or death. Around 95% of participants in this group were recorded as having experienced treatment failure, which in this trial included disease progression, death, stopping due to side effects, or choosing to withdraw. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00374322 · results posted 18 August 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,579 people in the lapatinib group and 1,582 in the placebo group — just over 3,100 participants in total. The trial was measuring whether lapatinib (at 1,500 mg daily) compared to a placebo made a difference in outcomes for people who had already been treated for breast cancer. The main thing being tracked was "disease-free survival" — that is, how many people experienced a return of their cancer, developed a new cancer, or died during the follow-up period. Several secondary measures were also tracked, including overall survival (deaths from any cause), the rate of cancer returning in the breast or nearby areas, cancer spreading to distant parts of the body, and cancer appearing in the brain or nervous system (called CNS recurrence). The reported data shows that for the primary measure, 252 people in the lapatinib group and 290 people in the placebo group experienced a disease recurrence, a new cancer, or died. For overall survival, 115 deaths were recorded in the lapatinib group compared to 126 in the placebo group, with 1,456 and 1,450 participants respectively not recorded as having died by the time of reporting. For the rate of cancer returning over time, the reported data shows that by the furthest time point measured, approximately 13.3% of the lapatinib group and 15.8% of the placebo group had experienced a recurrence. For cancer spreading to distant parts of the body, the figures at the furthest time point were approximately 9.3% in the lapatinib group and 11.1% in the placebo group. Regarding recurrence in the brain or nervous system, 15 people in the lapatinib group and 21 people in the placebo group were reported to have experienced this. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01276054 · results posted 1 August 2014

According to the results reported on ClinicalTrials.gov, this trial (NCT01276054) enrolled a total of four participants — two in a group receiving sentinel node biopsy or full lymph node removal combined with a treatment referred to as "ARM," and two in a group receiving sentinel node biopsy or full lymph node removal without ARM. The trial was measuring whether participants developed a condition called lymphoedema (LE) — a swelling in the arm caused by fluid build-up — defined as a greater than 5–10% increase in the size of the treated arm compared to the untreated arm. The reported data shows that none of the four participants completed the study, and all four did not finish for reasons not detailed in the submitted data. Because no participants completed the trial, no outcome measurement results were recorded or submitted for the primary outcome — that is, whether or not lymphoedema developed. The data was not reported for this measure. Given that the trial ended with no completed participants and no outcome data submitted, there are no numbers available to describe what the study found about lymphoedema rates in either group. The reported data shows only that the trial did not reach a point where results could be collected or analysed. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00925548 · results posted 24 July 2014

According to the results reported on ClinicalTrials.gov, this trial (NCT00925548) enrolled a total of 16 participants. Eleven people were assigned to receive tecemotide (also called L-BLP25) together with hormonal therapy and a drug called cyclophosphamide, while five people received a placebo (an inactive treatment) together with hormonal therapy and a saltwater solution. The trial was designed to measure how long participants went without their disease getting worse (called "progression-free survival"), as well as a number of other outcomes including how long participants lived overall, whether tumours shrank, how long any shrinkage lasted, and whether participants experienced at least some stabilisation of their disease. The reported data shows that, of the 11 participants in the active treatment group, only 1 completed the study, while 10 did not complete it. In the placebo group, none of the 5 participants completed the study. Despite the trial being set up to collect results for all of these outcomes, the reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of the outcome measures — not for the primary outcome (progression-free survival) or for any of the secondary outcomes (overall survival, tumour response, duration of response, clinical benefit, or time to progression). In other words, the actual figures for what happened to participants across all these measures were not reported in the data available on ClinicalTrials.gov. Because no outcome numbers were submitted, it is not possible to describe what the measurements showed for either group. The very small number of participants and the high proportion who did not finish the study may have contributed to this situation, but the reasons were not stated in the available data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01118624 · results posted 5 June 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 22 people, all of whom received a drug called pralatrexate. The trial was measuring how many participants' tumours shrank or disappeared (called the "objective response rate"), how long any such response lasted, how long participants lived overall, and how many participants experienced unwanted health events (called adverse events) or unusual results in their blood or other lab tests. The reported data shows that none of the 22 participants were recorded as having formally "completed" the study, with all 22 listed as not completing it — the reasons for this are not detailed in the data provided. The reported data shows that out of 22 participants, only 1 person's tumour responded to treatment (meaning it shrank to a defined degree). For that one person, the response lasted 112 days. The reported data also shows that the average length of time participants lived from their first dose of pralatrexate was 11.3 months, though it is important to note this is a group average and individual experiences are not described. Regarding unwanted health events, 21 out of 22 participants were reported as having experienced at least one adverse event or abnormal lab result — however, the data submitted does not break down the nature or seriousness of those events in the figures provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00301080 · results posted 2 December 2013

According to the results reported on ClinicalTrials.gov, this trial was testing a medicine called D-cycloserine (at different doses — 50 mg, 200 mg, and 250 mg) against a placebo (a dummy pill with no active ingredient) in people experiencing nerve pain related to cancer treatment. The trial went through two versions: an original shorter version lasting 4 weeks with two groups, and a revised longer version planned for 12 weeks with three groups. The main thing the trial set out to measure was how much participants' self-reported pain scores changed over the treatment period, using a standard questionnaire called the Brief Pain Inventory. The reported data shows that participation in this trial was very limited. In the original version, only 4 people were enrolled into the D-cycloserine 250 mg group and 3 into the placebo group, with 3 and 3 respectively completing the trial. The reported data shows that zero participants were recorded as starting or completing the revised 12-week version of the trial. As a result, no numerical results were reported for any of the outcome measures — not for the primary pain intensity scores, nor for any of the secondary measures, which included overall pain relief, nerve pain scores, how much pain interfered with daily life, or changes in opioid (strong painkiller) use. The data for all of these outcomes was not reported. Because so few people took part and no outcome measurement data was submitted, the reported data shows this trial did not produce findings that can be meaningfully described or compared across groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00499603 · results posted 31 October 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 50 people with breast cancer — 27 in a group receiving paclitaxel plus FEC (a combination chemotherapy regimen), and 23 in a group receiving the same chemotherapy plus an additional drug called RAD001 (also known as everolimus). All 27 participants in the first group and 22 of the 23 in the second group completed the study. The trial was primarily looking at whether a particular biological pathway in the tumour cells — known as the PI3K/PTEN/AKT pathway, which is involved in how cells grow — showed signs of being switched off (inhibited) after 48 hours of treatment. The trial also tracked how tumours responded at 12 and 24 weeks, using ultrasound scans to measure changes in tumour size. The reported data shows that for the primary measurement, all 27 participants in the paclitaxel plus FEC group and all 22 evaluable participants in the paclitaxel plus RAD001 plus FEC group had data recorded for this pathway activity at 48 hours, though the specific breakdown of how many showed inhibition versus activation is not broken down further in the submitted results. For tumour response at 12 weeks, the reported data shows that in the paclitaxel plus FEC group, 3 participants had a complete response, 5 had a partial response (tumour shrank by at least half), 16 had stable disease, and 3 had disease progression; in the paclitaxel plus RAD001 plus FEC group, 0 had a complete response, 11 had a partial response, 11 had stable disease, and 1 had progression. At 24 weeks, the paclitaxel plus FEC group had 4 complete responses, 16 partial responses, 7 with stable disease, and 0 with progression; the paclitaxel plus RAD001 plus FEC group had 2 complete responses, 11 partial responses, 7 with stable disease, and 3 with progression. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00140140 · results posted 24 October 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 16 people in total across three treatment groups. It was testing two chemotherapy medicines — ABI-007 (also known as nab-paclitaxel) and vinorelbine — given together at different dose combinations. The trial had two parts: Part 1 tested a lower dose combination with 4 participants, and Part 2 tested both a lower-dose group (6 participants) and a higher-dose group (6 participants). The trial was measuring how often tumours shrank or disappeared, how often side effects were serious enough to require dose changes or treatment stops, and how the combination affected participants' blood cell counts. The reported data shows that in terms of tumour response, 25% of participants in the Part 1 lower-dose group, 16.7% in the Part 2 lower-dose group, and 33.3% in the Part 2 higher-dose group had their tumours recorded as either completely or partially shrinking. Regarding serious side effects that required dose changes or long delays (called "dose limiting toxicities"), 2 participants in each of the three groups experienced these. For treatment interruptions or stops due to side effects, 50% of participants in both lower-dose groups had their treatment discontinued or delayed, compared to 17% in the higher-dose group. The reported data also shows that blood cell counts — which can drop during chemotherapy — fell to their lowest recorded points (called "nadirs") at varying levels across the groups, with all three groups recording some participants whose counts reached more concerning levels on a standard grading scale. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00337103 · results posted 30 September 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,102 people with breast cancer — 554 were assigned to receive a medicine called eribulin mesylate and 548 were assigned to receive capecitabine (another cancer medicine). The trial was primarily measuring two things: how long participants lived overall (called "overall survival"), and how long they lived before their disease got worse (called "progression-free survival"). None of the participants were recorded as having completed the study in the usual sense, as the data was collected up until a set cut-off date or until participants passed away. The reported data shows that, for overall survival, participants in the eribulin group had a median of 484 days, compared to 440 days in the capecitabine group. For progression-free survival — the time before the disease was seen to be getting worse — the reported figures were 126 days for the eribulin group and 129 days for the capecitabine group. When looking at how many participants showed a measurable reduction in their tumours (the "objective response rate"), the reported data shows 11.0% in the eribulin group and 11.5% in the capecitabine group. Among those who did show a response, the reported duration of that response was 198 days for the eribulin group and 330 days for the capecitabine group. The trial also measured quality of life using standard questionnaires. The reported data shows that changes from the starting point were generally small in both groups across most measures, with the capecitabine group showing slightly higher scores on some quality-of-life scales at week six. These differences were modest in size on the 0–100 scoring scales used. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00716482 · results posted 9 September 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,681 people who had breast lesions (abnormal areas found in the breast). Of these, 1,562 completed the study, while 119 did not complete it. The trial was looking at whether adding a type of imaging called Shear Wave Elastography (SWE) — a technique that measures the stiffness of tissue — to standard breast ultrasound could improve how accurately breast lesions were categorised. Specifically, it examined whether using SWE features could help reclassify lesions that had been given a "BI-RADS" rating, which is a standard scoring system doctors use to describe how concerning a breast lesion looks on imaging. The reported data shows that the primary analysis was based on 939 lesions and looked at two things: specificity (how well the method correctly identified lesions that were not cancerous) and sensitivity (how well it correctly identified lesions that were cancerous). The results were reported as numbers of participants falling into each category under different strategies — a "conservative" approach and a more "aggressive" approach to reclassifying lesions — but the data as submitted does not include percentage figures or a direct comparison summary, so a straightforward before-and-after number cannot be provided here. For the secondary outcomes, when the same investigator repeated SWE scans three times on the same lesions, the reported correlation figures (a measure of consistency, where 1.0 would be perfect agreement) ranged from 0.57 to 0.95 across different measurements. When two different observers assessed the same images, the agreement scores (called kappa values, where 1.0 is perfect agreement) ranged from 0.38 to 0.66. Regarding image consistency, most lesions scanned three times were rated "very homogeneous" (385 benign, 5 malignant), meaning the images looked very similar each time. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00093145 · results posted 17 July 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 32 participants, all of whom received a combination of three medicines: albumin-bound paclitaxel, carboplatin, and trastuzumab (Herceptin). The trial was measuring how participants' tumours responded to this combination — specifically, whether tumours shrank or disappeared, how long it took for the disease to progress, how long any response lasted, and how long participants survived overall. The reported data shows that 62.5% of participants (roughly 20 out of 32) had their tumours shrink or disappear to a degree that met the study's definition of a confirmed response. When the definition was broadened to also include people whose disease stayed stable for at least 16 weeks without shrinking or growing, 81.3% of participants fell into that combined group. The reported middle point for time until disease progression — meaning the point at which half the group had seen their disease worsen — was 16.6 months. For those who did show a response, the reported middle point for how long that response lasted was 17.8 months. Overall survival figures were listed as "not available" in the submitted data, so those numbers were not reported. Regarding unwanted medical events, all 32 participants experienced at least one adverse event (an unwanted or unexpected medical occurrence during the study), 31 experienced at least one that was considered related to the study treatment, 20 experienced a serious adverse event, and 5 experienced a life-threatening adverse event. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00022672 · results posted 13 June 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 207 people — 103 in a group receiving trastuzumab combined with anastrozole, and 104 receiving anastrozole alone. The trial was measuring how long participants went without their cancer growing or spreading (called "progression-free survival"), as well as a number of other outcomes such as overall survival, how many people saw their disease stabilise or shrink, and how long any response to treatment lasted. The study had a main phase of 24 months and an extension phase, though relatively few participants completed the full main phase — 16 in the combination group and 4 in the anastrozole-only group. The reported data shows that for the primary outcome — the time until the disease progressed or a participant died — the combination group had a median (middle value) of around 4.8 to 5.8 months, while the anastrozole-only group had a median of around 2.4 to 2.9 months (two sets of figures were reported, likely reflecting different analysis points). For the secondary outcomes, the reported data shows that approximately 42.7–45.6% of participants in the combination group and 27.9–30.8% in the anastrozole-only group met the definition of "clinical benefit" (meaning their disease stayed stable for at least six months, or shrank). The median time participants survived overall was reported as 28.5 months in the combination group and 23.9 months in the anastrozole-only group, and roughly 52.4% versus 45.2% of participants in each group respectively were alive at two years. The reported data also shows that among those whose disease did respond, the duration of that response was approximately 9.5 months in the combination group and 10.0 months in the anastrozole-only group, and the time it took for a response to first appear was 2.0 months in both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00088972 · results posted 9 April 2013

According to the results reported on ClinicalTrials.gov, this trial (NCT00088972) enrolled a total of 8 participants, split across two groups: 3 people in Arm I and 5 people in Arm II. The trial was designed to measure two things — changes in breast density (as seen on a mammogram, measured by the percentage of highlighted pixels on the image) and changes in a biological marker called Ki-67 (a protein that indicates how actively cells are dividing). The plan was to track these measurements over one year to compare any differences between the two groups. The reported data shows that of the 8 participants who started the trial, only 2 completed it — 1 from each arm. The remaining 6 participants (2 from Arm I and 4 from Arm II) did not complete the trial. Regarding the actual outcome measurements — the numbers for both the primary outcome (change in mammographic breast density) and the secondary outcome (Ki-67 expression levels) were not reported in the data submitted to ClinicalTrials.gov. Because no measurement results were provided for either outcome, it is not possible to describe what the numbers showed for either group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00372424 · results posted 30 October 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 26 people, all of whom received a combination of three medicines: sunitinib, docetaxel, and trastuzumab. The trial was primarily looking at how many participants experienced adverse events (unwanted medical occurrences) or serious adverse events during treatment. It also measured things like tumour response rates, how long it took for the disease to progress, how long any tumour response lasted, and how the medicines moved through the body in blood samples. Notably, none of the 26 participants completed the study, though 25 received at least one dose of treatment. The reported data shows that, of the 25 people treated, 24 experienced at least one treatment-emergent adverse event, and 11 experienced at least one serious adverse event. For the secondary outcomes, approximately 72.7% of participants showed an objective tumour response — meaning their tumours either disappeared or shrank by at least 30% based on scans. The reported median time before the disease progressed (or death occurred) was 58.4 weeks, and among those who responded to treatment, the response lasted a median of 51.3 weeks. The trial also recorded blood concentration levels of the medicines at various time points; these figures were reported across multiple measurements but are highly technical in nature and would require specialist interpretation. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00464646 · results posted 26 September 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 105 people across two groups. Cohort A included 76 people with HER2-positive locally advanced breast cancer who received treatment before surgery (called neoadjuvant treatment). Cohort B included 29 people with HER2-positive breast cancer who had already had surgery and received treatment afterwards (called adjuvant treatment). All 105 participants who started the trial completed it. The trial was measuring, among other things, how many people in Cohort A showed no remaining cancer cells in their breast tissue or lymph nodes after pre-surgery treatment, and how many people across both groups experienced serious heart-related events. The reported data shows that in Cohort A, 34 out of 76 participants had no detectable invasive cancer cells found in both the breast and lymph nodes when examined after surgery. A related but slightly broader measure — looking at the breast tissue only — found 36 out of 76 Cohort A participants had no invasive cancer cells there. For Cohort A, 61.43% of participants showed a complete response to treatment as measured by physical examination. Regarding serious heart events (defined as severe heart failure or cardiac death), 4 participants in Cohort A and 0 in Cohort B had such an event recorded. The reported data also shows that 55 out of 76 participants in Cohort A and 22 out of 29 in Cohort B experienced severe side effects (graded 3 or 4 in severity, including those related to radiation therapy). For survival free from cancer returning over five years, the reported figures were approximately 76% for Cohort A and approximately 90% for Cohort B. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00281697 · results posted 24 September 2012

According to the results reported on ClinicalTrials.gov, this trial (NCT00281697) enrolled 684 people with breast cancer — 459 in the group receiving standard chemotherapy plus bevacizumab, and 225 in the group receiving standard chemotherapy plus a placebo (an inactive substance used for comparison). The trial's main goal was to measure "progression-free survival" — that is, how long participants went before their disease was recorded as getting worse, or before they passed away, whichever came first. A number of secondary measurements were also taken, including how long people lived overall, how many were still alive after one year, and how many showed a measurable reduction in their cancer. The reported data shows that, for the main measure, the bevacizumab group had a median progression-free survival of 7.2 months, compared with 5.1 months in the placebo group. ("Median" means the middle value — half the people in each group experienced progression or death before that point, and half after.) For overall survival — time from enrolment until death from any cause — the reported figures were 18.6 months in the bevacizumab group and 17.8 months in the placebo group. The reported data shows that 70.5% of participants in the bevacizumab group and 68.6% in the placebo group were still alive at one year. In terms of measurable tumour response, 39.5% of participants in the bevacizumab group and 29.6% in the placebo group were recorded as having a complete or partial response. Among those who did respond, the duration of that response was reported as 7.3 months and 7.5 months respectively. When the results were broken down by the specific chemotherapy drug used alongside bevacizumab or placebo (taxanes, gemcitabine, capecitabine, or vinorelbine), the reported progression-free survival figures varied across the four drug groupings, ranging from 5.7 to 8.0 months in the bevacizumab group and 4.1 to 7.0 months in the placebo group. It is worth noting that a large proportion of participants in both groups — 401 out of 459 and 197 out of 225 respectively — did not complete the study, though the reasons for this were not detailed in the summary data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00503750 · results posted 14 June 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 27 participants, and all 27 completed the study. The trial looked at a treatment approach for breast cancer that involved two phases: first, a combination of trastuzumab (a targeted medicine) and Abraxane (a chemotherapy medicine), followed by trastuzumab combined with vinorelbine (another chemotherapy medicine). The main thing the trial was measuring was how many participants showed no remaining signs of invasive (actively spreading) breast cancer in the removed breast tissue after surgery — a result called a "pathologic complete response." The reported data shows that out of the 27 participants, 13 showed no remaining invasive breast cancer in their breast tissue at the time of surgery. For the secondary measurements — which looked at how tumours responded during treatment rather than after surgery — the reported data shows that 20 participants had a complete clinical response, meaning all measurable signs of disease disappeared during treatment. Seven participants had a partial response, meaning their tumour shrank by at least half. No participants were recorded as having stable disease, meaning no one fell into the category where the tumour neither shrank significantly nor grew. It is worth noting that this was a small study of 27 people, and the data as reported does not include longer-term follow-up outcomes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00768222 · results posted 25 August 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 101 people who needed surgical stitches — 50 were treated with Chinese Silk Suture and 51 with VICRYL Plus Suture. Of those, 46 and 47 participants respectively completed the trial. The trial was designed to compare two types of surgical thread (sutures) by measuring the appearance of the wound scar afterwards, as well as looking at signs of wound infection. The reported data shows that for the main outcome — scar appearance rated by an independent assessor using a scale from 0 (worst possible scar) to 100 (best possible scar) — the Chinese Silk Suture group scored an average of 45.4, while the VICRYL Plus Suture group scored an average of 67.2. For a secondary measure of wound appearance rated by the treating doctor on a scale of 0 (worst) to 6 (best), the reported data shows scores of around 5.0–5.2 for the Chinese Silk group and 5.7 for the VICRYL Plus group across two measurement time points. For wound infection, a separate scale was used where a score of 0–10 represents satisfactory healing; both groups recorded average scores in that satisfactory range across all three measurement time points, with the Chinese Silk group scoring between 1.4 and 1.6, and the VICRYL Plus group scoring between 0.9 and 1.2. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00471276 · results posted 22 July 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 83 participants, all of whom received the drug sunitinib. The trial was measuring how the drug affected participants' tumours, including whether tumours shrank, how long participants lived without their disease getting worse, and how long they survived overall. The reported data shows that none of the 83 participants were recorded as having formally "completed" the study — all 83 were listed as not completing it, though the data does not explain the reasons for this in detail. The reported data shows that 7 out of 83 participants had an "objective response," meaning their tumours either disappeared completely or shrank by at least 30%. When looking at a broader measure called "clinical benefit" — which also included people whose disease stayed stable for more than 6 months — 9 participants fell into that category. For tumours that could be assessed visually or by physical examination (such as skin or chest wall lesions), 3 participants showed a measurable response. The reported data also shows that, on average, participants went approximately 3.6 months before their disease progressed or they died — a measure known as progression-free survival. Among those who did respond to treatment, the response lasted an average of around 3.4 weeks. The average overall survival — meaning the time from starting the study until death from any cause — was reported as approximately 15.6 months. It is worth noting that these figures are averages across the group and individual experiences varied. The trial only had one group (sunitinib), so there was no comparison group reported in this data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00634088 · results posted 3 May 2011

According to the results reported on ClinicalTrials.gov, this trial (NCT00634088) enrolled a total of 10 participants across three dose-testing stages. The trial was designed to find the highest dose of two cancer medicines — ixabepilone and lapatinib — that could be given together without causing too many serious side effects. This type of trial is called a dose-finding or "Phase I" study. Participants were placed into different groups receiving different dose combinations: 6 people received ixabepilone at 32 mg/m² with lapatinib at 1,000 mg, 3 people received ixabepilone at 32 mg/m² with lapatinib at 1,250 mg, and 1 person received ixabepilone at 40 mg/m² with lapatinib at 1,250 mg. A planned fourth group testing a three-medicine combination (adding capecitabine) was not reported to have started. The reported data shows that the trial was closed before it reached its main goal — no final recommended dose was recorded in the submitted results. Regarding unwanted medical events (called adverse events), the reported data shows that across the three groups that did enrol, 3, 0, and 0 participants respectively experienced a death or serious medical event; 2, 0, and 1 experienced events that led to stopping treatment; and 6, 3, and 1 experienced events considered related to the study medicines. One participant in the lowest-dose group experienced what is defined as a "dose-limiting toxicity" — a side effect serious enough to set the upper limit for dosing — while none were reported in the other two groups. Blood test abnormalities were also recorded for some participants across the groups. The peak blood level (the highest amount of ixabepilone measured in the bloodstream) was reported as 200.6 ng/mL, 109.2 ng/mL, and 133.4 ng/mL for the three groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00393939 · results posted 28 February 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 593 people with breast cancer — 296 were assigned to receive a combination of two medicines (docetaxel plus sunitinib) and 297 received docetaxel alone. The main thing the trial was measuring was **progression-free survival** — that is, how long participants went before their cancer showed signs of growing or spreading, or before they died, whichever came first. The trial also tracked a number of secondary measures, including how many participants' tumours shrank (objective response), how long that shrinkage lasted (duration of response), how long participants lived overall (overall survival), and participants' quality of life. It is worth noting that no participants were recorded as having formally "completed" the study, which the reported data suggests reflects the nature of how the trial's endpoint was defined rather than dropout. The reported data shows that for the primary measure of progression-free survival, the combination group had a median of 8.6 months (a "median" is the middle value — half the group had a longer time, half a shorter time), compared with 8.3 months for the docetaxel-alone group. For objective response — the proportion of participants whose tumours shrank meaningfully — the reported figures were approximately 51% in the combination group and 39% in the docetaxel-alone group. The duration of that response was reported as a median of 7.5 months in the combination group and 7.2 months in the docetaxel-alone group. For overall survival, the reported median was 26.0 months in the combination group and 28.9 months in the docetaxel-alone group. The quality-of-life questionnaire results were not included in the data reported to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00373113 · results posted 18 November 2010

According to the results reported on ClinicalTrials.gov, this trial compared two treatments — sunitinib and capecitabine — in people with a specific type of cancer. A total of 238 people were assigned to the sunitinib group and 244 to the capecitabine group, making 482 participants in all. The trial's main goal was to measure "progression-free survival" — that is, how long participants went before their cancer showed signs of growing or spreading, or before they died from any cause, whichever came first. The reported data shows that, for the main measure, participants in the sunitinib group had a median progression-free survival of 2.8 months, compared with 4.2 months in the capecitabine group. (Median means the midpoint — half the participants in each group had a result above this figure and half below.) The reported data also shows that the time until the cancer first showed signs of growing was 2.8 months for sunitinib and 4.2 months for capecitabine. When looking at how many participants showed a measurable shrinkage in their tumours, 27 people in the sunitinib group and 40 people in the capecitabine group met this measure. Among those who did show a response, that response lasted a reported 6.9 months on average in the sunitinib group and 9.3 months in the capecitabine group. The average overall survival — time from the start of the trial until death from any cause — was reported as 15.3 months for sunitinib and 16.9 months for capecitabine. The time-to-tumour-response figures were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00089661 · results posted 26 January 2010

According to the results reported on ClinicalTrials.gov, this trial enrolled 252 participants — 127 received denosumab (60 mg every six months) and 125 received a placebo (an inactive dummy injection). The trial was measuring changes in bone mineral density (a scan-based measure of how dense and strong bones are) at three sites in the body: the lumbar spine (lower back), the total hip, and the femoral neck (the top of the thigh bone where it meets the hip). Measurements were taken at six months and twelve months into the study. By the end of the trial, 106 participants in the denosumab group and 99 in the placebo group had completed it. The reported data shows the following percentage changes in bone mineral density from the start of the trial. At the lumbar spine after 12 months, the denosumab group showed an average increase of 4.8%, while the placebo group showed an average decrease of 0.7%. At six months, those figures were +3.7% and −0.6% respectively. At the total hip after 12 months, the denosumab group showed an average increase of 3.1% compared to a decrease of 0.7% in the placebo group; at six months, the figures were +2.3% and −0.4%. At the femoral neck after 12 months, the denosumab group showed an average increase of 1.9% compared to a decrease of 0.6% in the placebo group; at six months, the figures were +1.2% and −0.9%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00191152 · results posted 8 December 2009

According to the results reported on ClinicalTrials.gov, this trial enrolled 239 people in one group (receiving gemcitabine plus docetaxel) and 236 in another group (receiving docetaxel plus capecitabine), for a total of 475 participants. The trial was measuring how long it took for the disease to progress — that is, how many months passed before the cancer got worse or participants died from the disease. Some participants who finished the initial treatment phase then crossed over to receive the other treatment combination, and similar measurements were tracked for that crossover phase as well. The reported data shows that for the main (primary) outcome — time to disease progression during the initial treatment — the gemcitabine plus docetaxel group had a reported figure of about 9.28 months, while the docetaxel plus capecitabine group had a figure of about 8.88 months. For a related measure called progression-free survival (which also counted deaths from any cause, not just the disease), the reported figures were 9.01 months and 8.88 months respectively. Among participants whose tumours responded to initial treatment, the time that response lasted was reported as approximately 9.11 months in the gemcitabine plus docetaxel group and 10.39 months in the docetaxel plus capecitabine group. For those who crossed over to the other treatment, the reported data shows time to disease progression of approximately 4.51 months for those who switched to capecitabine, and 2.34 months for those who switched to gemcitabine. Among the smaller number of crossover participants whose tumours responded, the duration of that response was reported as approximately 25.89 months for the capecitabine crossover group and 42.50 months for the gemcitabine crossover group, though these latter figures applied to a much smaller subset of people and the data was not reported for all participants in every category. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00082433 · results posted 17 August 2009

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,221 people with breast cancer — 609 in a group receiving a combination of two medicines (ixabepilone plus capecitabine) and 612 in a group receiving capecitabine alone. The trial was primarily looking at how long it took for the cancer to start growing again or for participants to pass away (called "progression-free survival"), as well as a number of other measures including how many participants' tumours shrank, how long that shrinkage lasted, and how participants reported feeling during treatment. The reported data shows that, on average, the time before the cancer progressed was 6.24 months in the combination group and 4.40 months in the capecitabine-only group. When it came to tumour shrinkage, 43.3% of participants in the combination group had their tumours shrink to a meaningful degree, compared with 28.8% in the capecitabine-only group. Among those whose tumours did shrink, the reported data shows the shrinkage lasted a median of 6.1 months in the combination group and 6.3 months in the capecitabine-only group. The time it took for tumours to first start shrinking was reported as 6.6 weeks in both groups. Regarding how participants reported their symptoms on a quality-of-life questionnaire (where higher scores mean fewer symptoms), the reported data shows scores generally declined over time in the combination group and remained more stable or improved slightly in the capecitabine-only group, though the full breakdown of those figures was not clearly separable from the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.