Trial 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
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.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 32188717) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Breast Cancer Trial, Completed
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility 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
Who may be able to join
- You are female and have gone through menopause
- You have been diagnosed with invasive breast cancer, confirmed by a tissue sample (biopsy)
- Your tumor is at least 2 centimeters in size, measured by MRI scan
- Your cancer is classified as Stage I to operable Stage III (meaning it has not spread too far and surgery is possible)
- There is no evidence that your cancer has spread to other parts of the body
- Your breast cancer tests positive for estrogen receptors (ER+) and negative for a protein called HER2 (HER2-)
- Your cancer is suitable for surgical removal
- A biopsy sample from your tumor can be tested at a central lab for a specific gene change (PIK3CA mutation)
- You are generally able to carry out daily activities with little to no limitation (confirm with trial site)
- Your fasting blood sugar level is 125 mg/dL or below
- Your blood counts, kidney function, and liver function are within acceptable ranges (confirm with trial site)
- You are able and willing to attend all study visits and follow the study requirements
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- You have had any previous treatment for your current invasive breast cancer
- Your tumor is classified as a very advanced local stage (cT4 or cN3) (confirm with trial site)
- You have breast cancer in both breasts, in multiple areas of the breast, or cancer that has already spread to other parts of the body
- You have already had surgery to remove the tumor, lymph nodes, or a sentinel lymph node biopsy
- You have Type 1 or Type 2 diabetes and take medication to control your blood sugar
- You are unable or unwilling to swallow pills
- You have a condition that affects how your body absorbs food or medication through the gut
- You have a history of or currently have inflammatory bowel conditions such as Crohn's disease or ulcerative colitis
- You have a heart condition involving an abnormal heart rhythm called long QT syndrome, or an abnormal result on a specific heart test (confirm with trial site)
- Your lung function test shows reduced ability to transfer oxygen into the blood (below 60% of expected) (confirm with trial site)
- You have significant heart or cardiovascular problems, including uncontrolled high blood pressure, unstable chest pain, a history of heart attack, or moderate to severe heart failure
- You have any reason you cannot have an MRI scan (for example, a pacemaker or metal implants)
- You currently have an active infection being treated with intravenous (IV) antibiotics
- You need supplemental oxygen every day
- You have a significant liver condition, including hepatitis, active alcohol misuse, or cirrhosis
- You have any other serious uncontrolled illness, lung condition, or metabolic problem that the study team considers a risk (confirm with trial site)
- You have had a serious injury in the 3 weeks before starting the study treatment
- You have had a major surgical procedure in the 4 weeks before starting the study treatment
- You have had another cancer in the past 5 years, with some exceptions such as certain early-stage or skin cancers (confirm with trial site)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Trial contact details on record
Principal Investigator: Clinical Trials, Hoffmann-La Roche
Australian sites
This trial is not accepting new participants. These are the contact details ClinicalTrials.gov holds for it, kept here for reference. They are not an invitation to enrol, and the sites listed may no longer be running this trial.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial was run
These are the locations recorded on the registry, including 5 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
Percentage of Participants With Objective Response (OR) by Centrally Assessed Breast Magnetic Resonance Imaging (MRI) Via Modified Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1; Percentage of Participants With Total Pathologic Complete Response (Total pCR), Defined as Having pCR in Both Breast and Axilla, Using American Joint Committee on Cancer (AJCC) Staging System; Percentage of Participants With OR by Centrally Assessed Breast MRI Via mRECIST Version 1.1 in Phosphatidylinositol-4,5-Bisphosphate 3-Kinase, Catalytic Subunit Alpha (PIK3CA) Mutant (MT) Participants; Percen...
Other options
Data last synced from ClinicalTrials.gov: 9 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.