RecruitingPhase 3NCT06846437

JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer

A Randomized, Controlled, Open-Label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer Subjects


Sponsor

Shanghai JMT-Bio Inc.

Enrollment

228 participants

Start Date

Feb 18, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new drug called JSKN003 to an existing standard treatment (trastuzumab emtansine, also known as T-DM1) in people with HER2-positive advanced breast cancer — a type of breast cancer driven by overexpression of a protein called HER2. **You may be eligible if...** - You are 18 or older with confirmed HER2-positive advanced or metastatic breast cancer - Your cancer is not surgically removable - You have already received a HER2-targeted treatment (like trastuzumab) and your cancer has since progressed **You may NOT be eligible if...** - You have previously received T-DM1 treatment - You have active brain metastases that are unstable - You have significant heart problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJSKN003

Administered intravenously according to protocol.

DRUGTrastuzumab emtansine (T-DM1)

Administered intravenously according to the approved label.


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, China

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NCT06846437