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

NCT06079983 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-09-12

No results posted yet for this study

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

Conditions

Interventions

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).

Sponsors & Collaborators

  • Jiangsu Alphamab Biopharmaceuticals Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Erwei Song · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  • Jiong Wu · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06079983 on ClinicalTrials.gov