drugset / Trial / NCT06079983

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

NCT06079983

Phase 3 Recruiting 400 enrolled Jiangsu Alphamab Biopharmaceuticals Co., Ltd
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a randomized controlled, open-label, multicenter phase III clinical study evaluating the efficacy and safety of chemotherapy selected by investigator JSKN003 s in subjects with recurrent or metastatic breast cancer who have previously failed first- or second-line chemotherapy in subjects with recurrent or metastatic breast cancer who have failed prior first- or second-line chemotherapy. The study planned to enroll 408 subjects in a 1:1 ratio and stratified block randomization method assigned to: * Experimental group: JSKN003 monotherapy * Control group: investigator's chosen chemotherapy drug (capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin) monotherapy

Timeline

Start
2023-12-01
Primary completion
2026-04-01
Completion
2029-03-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Capecitabine Small molecule
Comparator Docetaxel Small molecule
Comparator Eribulin Small molecule
Comparator Gemcitabine Small molecule
Subject JSKN003 Monoclonal antibody Intravenous
Comparator Paclitaxel Small molecule
Comparator Vinorelbine Small molecule

Indications