drugset / Trial / NCT06079983
JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — | — |