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

Breast Cancer Clinical Trial

Official title:
A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Trial Of JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects

Clinical Trial 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 400 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

Clinical Trial Description

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 400 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06079983
Study type Interventional
Source Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Contact Erwei Song
Phone 020-81332507
Email songew@mail.sysu.edu.cn
Status Not yet recruiting
Phase Phase 3
Start date December 1, 2023
Completion date March 1, 2029
View Details
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