Phase 3 Trial Comparing JSKN003 Versus Doctors Choice Chemotherapy for Adults with HER2-low Unresectable or Metastatic Breast Cancer After Prior Chemotherapy

What this Trial Is About

Researchers are evaluating a new chemotherapy drug called JSKN003 in people with recurrent or metastatic breast cancer that is HER2-low and cannot be removed by surgery. This phase III clinical trial compares JSKN003 to chemotherapy drugs chosen by doctors in patients who have already tried and not responded to one or two previous chemotherapy treatments. The study aims to assess the safety and effectiveness of JSKN003 in this group of patients. Participants are randomly assigned to one of two groups one group receives JSKN003 alone given by intravenous infusion, while the other group receives one chemotherapy drug selected by their doctor from options like capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin. The choice of the chemotherapy drug for the control group is made before randomization. Treatment schedules follow the study protocol at multiple centers. During the study, participants will have regular assessments including scans to measure tumor progression and other tests to evaluate response and overall survival, monitored for up to about three years after enrollment. Researchers will track progression-free survival as the main outcome, along with overall survival, response rate, and duration of response. Safety and side effects will also be closely monitored throughout the study.

JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects