NCT07461454 YL202 Versus Treatment of Physician's Choice in Patients With HR+/HER2- Breast Cancer
| NCT ID | NCT07461454 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | MediLink Therapeutics (Suzhou) Co., Ltd. |
| Condition | Locally Advanced or Metastatic Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 376 participants |
| Start Date | 2026-03-17 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 376 participants in total. It began in 2026-03-17 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study will evaluate the safety and efficacy of YL202, when compared with treatment of physician's choice (eribulin, capecitabine, vinorelbine, gemcitabine or sacituzumab govitecan) in participants with unresectable locally advanced, recurrent or metastatic hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer who had failed at least one line of chemotherapy.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07461454 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Locally Advanced or Metastatic Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07461454 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 376 participants.
Is NCT07461454 currently recruiting?
Yes, NCT07461454 is actively recruiting participants. Contact the research team at clinicaltrials@medilinkthera.com for enrollment information.
Where is the NCT07461454 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07461454 clinical trial?
NCT07461454 is sponsored by MediLink Therapeutics (Suzhou) Co., Ltd.. The trial plans to enroll 376 participants.
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