Printed from Voxsanity (voxsanity.com.au) — NCT06548178 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Breast Cancer Trial, Not Yet Recruiting
NCT06548178
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
- Women aged 18 or older at the time of being assigned to a treatment group.
- People diagnosed with invasive breast cancer that has not yet been treated, where the cancer tests positive for HER2 (a protein found on some cancer cells), confirmed by local laboratory testing according to standard guidelines within the past 6 weeks before joining the trial.
- People whose cancer is at a specific stage at diagnosis: the tumour in the breast is larger than 2cm but no larger than 5cm, there is no sign of cancer in nearby lymph nodes, and no sign the cancer has spread to other parts of the body.
- People who are able to read, understand, and sign a consent form agreeing to take part in the trial and follow its requirements.
- People whose heart is pumping at least 50% of its normal capacity, confirmed by a heart scan taken within 28 days before being assigned to a treatment group.
- People who are generally well enough to carry out daily activities with little or no limitation, as measured by a standard medical scale (ECOG performance status of 0 or 1).
- People whose blood counts, liver function, kidney function, and other organ measures fall within the required ranges, tested within 14 days before being assigned to a treatment group (specific thresholds apply — confirm with trial site). Note: Blood transfusions or certain blood-boosting injections are not permitted within 14 days before these tests or between the tests and the start of treatment.
- People who have waited long enough after any previous treatments before joining the trial, with the required waiting period depending on the type of treatment received (waiting periods range from 1 week to 6 weeks depending on the treatment type — confirm specific requirements with trial site).
- Women who have gone through menopause, or women who could potentially become pregnant and have a negative blood pregnancy test at the screening visit, with further urine pregnancy tests required before each dose of study treatment.
- Women who could potentially become pregnant are defined as those who have not had surgery to prevent pregnancy (such as removal of both ovaries, both fallopian tubes, or the uterus) and have not gone through menopause (defined as no menstrual period for 12 months without another medical explanation).
- Women must agree not to donate or store eggs for their own use from the time they join the trial until at least 7 months after the last dose of study treatment, and must not breastfeed during this time. Storing eggs before joining the trial may be considered.
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.
- People whose breast cancer cannot be treated with surgery, including those with inflammatory breast cancer (a type that causes redness and swelling of the breast).
- People who have previously been diagnosed with invasive breast cancer at any time.
- People who have had more than one cancer diagnosis within the past 3 years, with some exceptions: certain skin cancers that were fully removed, cancers that were treated and fully cured while still in an early non-spreading stage, or other solid cancers that were fully cured.
- People who have any signs that the cancer has already spread to other parts of the body, confirmed by scans or other tests used in standard care.
- People who have previously or are currently receiving chemotherapy-type treatments for any reason related to cancer.
- People who are currently taking part in another clinical trial or who have received any experimental treatment within 30 days before joining this trial.
- People with serious other health conditions that could interfere with receiving the study treatments or taking part in the trial, or whose organ function is not adequate.
- People who are considered unlikely to follow the trial requirements reliably (confirm with trial site).
- Women who are capable of becoming pregnant and are not using highly effective contraception during the study treatment period and for 3 months after treatment ends.
- People using hormonal contraception (such as the pill, patch, injection, or implant) or hormonal replacement therapy.
- People with substance use issues or other medical or psychological conditions that, in the opinion of the trial doctor, could interfere with participation in the trial or affect the reliability of results.
- People who have had a heart attack within the 6 months before being assigned to a treatment group, or who have moderate to severe heart failure symptoms. People with elevated heart enzyme levels (troponin) at screening without heart-related symptoms may need a heart specialist review before joining (confirm with trial site).
- People whose heart's electrical activity shows a prolonged measurement (QTcF greater than 470 milliseconds in females) on a heart tracing (ECG) taken at screening.
- People who have previously had to stop a medication because it caused heart rhythm problems, or who are currently taking any medication known to affect heart rhythm in a specific dangerous way.
- People who were born with a condition that affects heart rhythm, have a family history of such a condition, or have a first-degree relative who died suddenly and unexpectedly before the age of 40.
- People who have a history of lung inflammation (not caused by infection) that required steroid treatment, who currently have lung inflammation, or where lung inflammation cannot be ruled out by scans at screening.
- People with significant ongoing lung conditions, including but not limited to: a blood clot in the lungs within the past 3 months, severe asthma, severe chronic obstructive lung disease, restrictive lung disease, or fluid around the lungs.
- People with autoimmune, connective tissue, or inflammatory conditions (such as rheumatoid arthritis, Sjögren's syndrome, or sarcoidosis) where there is known or suspected involvement of the lungs at the time of screening.
- People who have had a complete surgical removal of one entire lung in the past.
- People with an active infection that requires treatment through a drip (intravenous antibiotics, antivirals, or antifungals).
- People with a primary immune system disorder, uncontrolled HIV infection, or active hepatitis B or C infection. People with a past hepatitis C infection may be eligible if a specific blood test shows the virus is no longer active. HIV testing may be required depending on local rules (confirm with trial site).
- People who have received a live or weakened live vaccine within 30 days before the first dose of study treatment. (Note: mRNA vaccines and certain adenoviral vaccines are not considered live vaccines.) People who join the trial should also not receive live vaccines during the trial or within 30 days after the last dose of study treatment.
- People who still have side effects from previous cancer treatments that have not recovered to a mild level or returned to their pre-treatment baseline, with the exception of hair loss. Note: People with certain stable, ongoing mild-to-moderate side effects that have been present without worsening for at least 3 months and are being managed with standard care may still be considered — such as nerve damage from chemotherapy, fatigue, certain hormone-related side effects from previous immunotherapy (such as thyroid problems, type 1 diabetes, high blood sugar, adrenal conditions, or skin pigment changes) — confirm with trial site.
- People who are known to be allergic or to have had a reaction to the study drug (T-DXd) or any of its ingredients.
- People who have had a severe allergic reaction to other similar antibody-based medicines in the past.
- People who are currently pregnant, breastfeeding, or planning to become pregnant.
- People with a history of certain serious heart rhythm problems that cause symptoms or require treatment, or uncontrolled irregular heartbeat despite treatment, or a sustained fast heartbeat from the lower chambers of the heart without symptoms. People with irregular heartbeat controlled by medication or a pacemaker may be considered after discussion with the trial doctor.
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.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Contact this trial
Phone: 86-021-64175590
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
1 September 2024
Est. completion
1 September 2025
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery
Can't join this trial?
Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.