Clinical Trial

A Phase III Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Triple-Negative Breast Cancer Who Have Failed Standard of Care

Recruiting Phase 3
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Summary
Primary Endpoint of this Study: To compare Progression-Free Survival (PFS) (as assessed by a Blinded Independent Review Committee \[BIRC\] based on Response Evaluation Criteria in Solid Tumors \[RECIST v1.1\]) between JSKN016 and Treatment of Physician's Choice (TPC) in participants with unresectable locally advanced, recurrent, or metastatic triple-negative breast cancer (TNBC). To compare Overall Survival (OS) between JSKN016 and TPC in the treatment of unresectable locally advanced, recurrent, or metastatic TNBC.
Trial Details
NCT Number NCT07533123
Lead Sponsor Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Conditions Triple Negative Breast Cancer
Enrollment 364 participants
Start Date 2026-03-17
Primary Completion 2029-03-17 (estimated)
Study Completion 2030-03-17 (estimated)
Updated on ClinicalTrials.gov 2026-04-16