YL202 vs physician's choice in HR+/HER2- breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 study compares the safety and effectiveness of YL202 to a physician's choice regimen (including eribulin, capecitabine, gemcitabine, vinorelbine, or sacituzumab govitecan) in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer after at least one prior chemotherapy. Eligible participants have measurable disease, good performance status, and adequate organ function, with tumor tissue available for analysis. The trial is being conducted at the Fudan University Shanghai Cancer Center with MediLink Therapeutics (Suzhou) as the lead sponsor. Primary goals include determining whether YL202 improves outcomes compared with standard options chosen by treating physicians. Safety will be monitored throughout the study to assess tolerability of the investigational agent.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Have been informed of the study before the start of the study and voluntarily sign name and date on the informed consent form.
2. Histologically and/or cytologically confirmed locally advanced or metastatic HR+/HER2- breast cancer who are not candidates for curative surgery or radiotherapy.
3. Patients who had failed at least one line of systemic chemotherapy in unresectable locally advanced, recurrent, or metastatic stage.
4. Have at least 1 extracranial measurable lesion as a target lesion per RECIST 1.1.
5. Tumor tissue samples can be provided at the time of diagnosis of locally advanced or metastatic tumors.
6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
7. Have Adequate organ and bone marrow function within 7 days prior to the first dose.
8. Female patients of childbearing potential must agree to use highly effective contraception from screening throughout the duration of the study and for at least 6 months after the last dose of study drug.
9. Have a expected survival ≥ 3 months.
10. Have ability and willingness to comply with protocol-specified visits and procedures.

Exclusion Criteria:

1. Have prior treatment with an agent targeting HER3.
2. Have prior treatment with topoisomerase I inhibitor or an ADC that consists of topoisomerase I inhibitor.
3. Have insufficient washout period for prior anticancer therapy prior to first dose of the study drug.
4. Have major surgery (excluding diagnostic surgery) within 4 weeks prior to the first dose of study drug or anticipation of major surgery during the study.
5. Leptomeningeal metastases or carcinomatous meningitis, spinal cord compression.
6. Have uncontrolled or clinically significant cardiovascular and cerebrovascular disease.
7. Have clinically significant concomitant pulmonary diseases.
8. Have uncontrolled pleural effusion, abdominal effusion.
9. Have serious infection within 4 weeks prior to the first dose.
10. Have a history of severe hypersensitivity reactions to the drug substance, inactive ingredients in the drug product, or other monoclonal antibodies.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Medilink Study Team
• Email: clinicaltrials@medilinkthera.com
• Phone: +86 0512-62858368

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.