drugset / Trial / NCT07461454

YL202 Versus Treatment of Physician's Choice in Patients With HR+/HER2- Breast Cancer

NCT07461454

Phase 3 Recruiting 376 enrolled MediLink Therapeutics (Suzhou) Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-03-17
Primary completion
2027-12-31
Completion
2028-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Capecitabine Small molecule 1000 mg/m2
Comparator Capecitabine Small molecule 1250 mg/m2
Comparator Eribulin Small molecule 1.4 mg/m2 Intravenous
Comparator Gemcitabine Small molecule 1000 mg/m2 Intravenous
Comparator Sacituzumab Govitecan Monoclonal antibody 10 mg/kg Intravenous
Comparator Vinorelbine Small molecule 25 mg/m2 Intravenous
Subject YL202 Unknown Intravenous

Indications