NCT06079983

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	JSKN003	Administered intravenously according to protocol.
DRUG	Capecitabine tablets	Administered according to protocol, as one option for investigator's choice (determined before randomization).
DRUG	Gemcitabine hydrochloride for injection	Administered according to protocol, as one option for investigator's choice (determined before randomization).
DRUG	Vinorelbine tartrate injection	Administered according to protocol, as one option for investigator's choice (determined before randomization).
DRUG	Paclitaxel for injection (albumin-bound type)	Administered according to protocol, as one option for investigator's choice (determined before randomization).
DRUG	Docetaxel injection	Administered according to protocol, as one option for investigator's choice (determined before randomization).
DRUG	Eribulin mesylate injection	Administered according to protocol, as one option for investigator's choice (determined before randomization).

Timeline

• Start date: 2023-12-01
• Primary completion: 2026-04-01
• Completion: 2029-03-01
• First posted: 2023-10-12
• Last updated: 2025-09-12

Locations

87 sites across 1 country: China