Phase 3 Breast Cancer Trial, Recruiting
Who may 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 might be able to join this trial:
- You have been diagnosed with breast cancer that is HR-positive and HER2-negative, and the cancer has spread locally or to other parts of the body and cannot be removed by surgery or treated with radiation to cure it.
- You have previously been treated with a type of drug called a CDK4/6 inhibitor (such as palbociclib, ribociclib, or abemaciclib) combined with hormone therapy, either for advanced/metastatic disease or after surgery, and your cancer got worse during that treatment or within 12 months of finishing it.
- You have previously received a CDK4/6 inhibitor or hormone therapy alone or in combination as a re-treatment, or you have previously received a treatment that targets specific gene-related proteins called ESR1 or BRCA1/2.
- Your cancer can be measured on scans according to standard medical guidelines, or you have cancer that has spread only to the bones in a way that cannot be directly measured.
- You are generally well enough to carry out daily activities with little to no limitation (confirm with trial site).
Who may not be able to join:
- Tests on your tumour tissue have found specific gene changes known as PIK3CA, AKT1, or PTEN alterations.
- You have already received more than two rounds of systemic (whole-body) treatment for your advanced or metastatic cancer.
- You have previously received chemotherapy — including a type called antibody drug conjugates (ADCs) — for advanced or metastatic disease. (Note: chemotherapy given before or after surgery for early-stage cancer does not disqualify you.)
- You have a medical or mental health condition that could make it unsafe or unsuitable for you to take part in the trial.
- You have significant problems with your kidneys, liver, or blood cell counts (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.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
3 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Progression Free Survival (PFS) as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Can't join this trial?
Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.