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 a type of breast cancer that is hormone receptor positive (HR+) and HER2 negative, and the cancer has either spread to other parts of the body or is locally advanced and cannot be completely removed by surgery
- Your cancer has been tested and confirmed through a biopsy (a tissue sample taken during or after your most recent treatment) to have certain specific characteristics related to hormone receptors, HER2, and a protein called HER3
- Your cancer got worse or came back while you were being treated with a specific combination of drugs called a CDK4/6 inhibitor plus hormone therapy — either as your first treatment for advanced cancer, or during or within 2 years of finishing a similar combination given after surgery
- Your cancer can be measured on scans using standard medical guidelines (confirm with trial site)
- If you have HIV, it must be well controlled with medication
- You are in good general health, able to carry out daily activities with little or no limitation, as assessed by your doctor within 7 days before joining the trial
Who may not be able to join:
- Your breast cancer could potentially be cured with treatment
- Your doctor believes you could still benefit from further hormone-based treatments for advanced disease
- You carry a specific inherited gene change (BRCA mutation) where a type of drug called a PARP inhibitor could be used to treat you
- Your cancer is causing or is about to cause serious, life-threatening problems with your internal organs
- Your blood oxygen level at rest is below 92%, or you need oxygen support at any time
- You have serious, uncontrolled heart or blood vessel disease
- You have moderate or severe nerve damage causing numbness, tingling, or pain (Grade 2 or higher peripheral neuropathy)
- You have a significant eye or cornea condition
- You have previously received chemotherapy for advanced or metastatic breast cancer
- You have previously been treated with a specific type of drug that targets the HER3 protein, or a drug combining an antibody with a chemotherapy agent that works in a similar way to the drug being studied in this trial
- You have received cancer treatment too recently before joining the trial (within 4 weeks or 5 half-lives, whichever is shorter — though patients previously on hormone therapy plus a CDK4/6 inhibitor may qualify if at least 2 weeks have passed)
- You have had radiotherapy to areas other than the brain within 14 days before starting the trial, or needed steroids because of radiation side effects in that time
- You have a condition that weakens your immune system, or you regularly take steroid medications
- You have another cancer that is active or has required treatment within the past 3 years
- You have a history of lung inflammation (pneumonitis or interstitial lung disease) that needed steroids, or you currently have or may have this condition
- You have had a severe allergic reaction to the study drug or any of its ingredients
- You have had a severe allergic reaction to all of the alternative standard treatments used in this trial (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.
Contact this trial
Principal Investigator: Medical Director, Merck Sharp & Dohme LLC
Phone: 1-888-577-8839
Australian sites
02 8670 5077
+61 2 85140922
+61 3 85722941
03 9076 2000
08 6457 3333
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
Where this trial is recruiting
5 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Progression Free Survival (PFS); Overall Survival (OS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.