Phase III Study Comparing JSKN016 to Doctors Choice Treatment in Adults Aged 18 to 75 with Advanced or Recurrent Triple-Negative Breast Cancer After Two Prior Chemotherapies

What this Trial Is About

Researchers are studying the effectiveness of JSKN016 compared to the Treatment of Physicians Choice TPC in patients with unresectable locally advanced, recurrent, or metastatic triple-negative breast cancer TNBC who have not responded to at least two prior systemic chemotherapy treatments. The study focuses on measuring progression-free survival PFS and overall survival OS to understand how well JSKN016 works against this aggressive form of breast cancer. Participants will be randomly assigned to receive either JSKN016 or one of several physician-chosen treatments, including eribulin, capecitabine, gemcitabine, vinorelbine, or sacituzumab govitecan. JSKN016 is given as an intravenous infusion at a dose of 6 mgkg on Day 1 of each 21-day cycle. Comparator drugs are administered according to their individual schedules within the same 21-day cycle framework. The trial is open-label, meaning both participants and doctors know which treatment is given. Throughout the study, participants will be monitored for tumor progression using standard response criteria and followed for survival outcomes for up to approximately three years after enrollment. Researchers will assess tumor response through imaging and other evaluations, track safety, and collect tumor tissue samples. Participants must be between 18 and 75 years old with adequate organ function and measurable disease. The trial duration and assessments are designed to provide comprehensive data on treatment impact and participant well-being.

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