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:
- People who have been fully informed about the study and have voluntarily signed and dated a consent form before the study begins.
- People who have been confirmed through tissue or cell testing to have locally advanced or metastatic breast cancer that is hormone receptor positive (HR+) and HER2 negative, and who are not suitable for curative surgery or radiation therapy.
- People whose cancer has not responded to at least one course of chemotherapy for advanced, returning, or metastatic disease.
- People who have at least one measurable area of cancer outside the brain that can be tracked during the study, according to standard measurement guidelines.
- People who are able to provide a tumour tissue sample taken at the time their advanced or metastatic cancer was diagnosed.
- People with a general health and activity score of 0 or 1 on a standard medical scale, meaning they are fully active or have only minor restrictions on physical activity.
- People with adequate organ and bone marrow function, confirmed by tests done within 7 days before the first study treatment.
- Women of childbearing potential who agree to use highly effective contraception from the screening period throughout the study and for at least 6 months after the last dose of study treatment.
- People with an expected survival of at least 3 months.
- People who are able and willing to attend all required study visits and follow the study procedures.
Who may not be able to join:
- People who have previously been treated with a therapy that specifically targets the HER3 protein.
- People who have previously received a type of chemotherapy called a topoisomerase I inhibitor, or an antibody-drug combination treatment containing one.
- People who have not waited long enough after their last cancer treatment before starting the study drug (confirm with trial site for specific timeframes).
- People who have had major surgery (not including diagnostic procedures) within 4 weeks before the first dose, or who are expected to need major surgery during the study.
- People who have cancer that has spread to the membranes surrounding the brain or spinal cord, or who have compression of the spinal cord.
- People with serious heart or blood vessel conditions that are not well controlled.
- People with significant ongoing lung disease.
- People with uncontrolled fluid build-up around the lungs or in the abdomen.
- People who have had a serious infection within 4 weeks before the first dose of study treatment.
- People who have had severe allergic reactions to the study drug's ingredients or to other similar antibody-based medicines.
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
Phone: +86 0512-62858368
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
Primary endpoints
Progression-free survival (PFS) assessed by BIRC per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
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.