JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer
NCT06846437 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 228
Last updated 2025-03-24
Summary
This study is designed to compare the safety and efficacy of JSKN003 versus T-DM1 in unrespectable locally advanced and/or metastatic HER2-positive breast cancer participants previously treated with trastuzumab and taxane.
Conditions
- Unrespectable Locally Advanced and or Metastatic HER2 Positive Breast Cancer Participants
Interventions
- DRUG
-
Administered intravenously according to protocol.
- DRUG
-
Trastuzumab emtansine (T-DM1)
Administered intravenously according to the approved label.
Sponsors & Collaborators
-
Shanghai JMT-Bio Inc.
lead INDUSTRY
Principal Investigators
-
Zhimin Shao, M.D. Organizational Affiliatio · 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
- 2025-02-18
- Primary Completion
- 2026-10-13
- Completion
- 2028-12-31
Countries
- China
Study Locations
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