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

Sponsor
MediLink Therapeutics (Suzhou) Co., Ltd.
Study ID
NCT07461454
Phase
PHASE3
Status
Recruiting
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Conditions

  • Locally Advanced or Metastatic Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 17, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
376 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: YL202
  • Active Comparator: Treatment of Physician's Choice (TPC)
    TPC,Eribulin, capecitabine, gemcitabine, vinorelbine or sacituzumab govitecan

Primary Outcome Measure

Progression-free survival (PFS) assessed by BIRC per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. [ Time Frame: up to 18 months ]

Central Contacts