NCT07461454

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

A Randomized, Open-label, Multicenter, Phase 3 Study of YL202 Versus Treatment of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 376 (estimated)
• Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Locally Advanced or Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	YL202	IV infusion on day 1 of each 21 day cycle
DRUG	Eribulin	1.4 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle
DRUG	Capecitabine	1000 or 1250 mg/m2, po, bid, from day 1 to Day 14 of each 21 day cycle
DRUG	Gemcitabine	1000 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle
DRUG	Vinorelbine	25 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle
DRUG	Sacituzumab govitecan	10 mg/kg, IV infusion on day 1 and Day 8 of each 21 day cycle

Timeline

• Start date: 2026-03-10
• Primary completion: 2027-12-31
• Completion: 2028-06-30
• First posted: 2026-03-10
• Last updated: 2026-03-10

Locations

1 site across 1 country: China