RecruitingPhase 3NCT06313086

DP303c Versus Trastuzumab Emtansine in in Patients With HER2-positive Advanced Breast Cancer

A Multicentre, Randomized, Open-label, Controlled Phase Ш Clinical Study to Evaluate the Efficacy and Safety of DP303c Versus Trastuzumab Emtansine in Patients With HER2-positive Advanced Breast Cancer


Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Enrollment

442 participants

Start Date

Mar 13, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

A Clinical Study to Evaluate the Efficacy and Safety of DP303c versus trastuzumab emtansine in patients with HER2-positive Advanced Breast Cancer


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares a new drug called DP303c against the standard treatment T-DM1 (trastuzumab emtansine) for patients with HER2-positive advanced breast cancer. HER2-positive means the cancer cells have too many copies of a protein that drives growth, and both drugs target that protein. **You may be eligible if...** - You are 18 or older with locally advanced or metastatic breast cancer (cannot be surgically removed) - Your cancer has been confirmed HER2-positive by lab testing - You have previously received both trastuzumab (Herceptin) and a taxane chemotherapy for advanced disease - You have reasonable physical function (ECOG 0–2) and adequate organ function - Your life expectancy is at least 3 months - You agree to use effective contraception during the study **You may NOT be eligible if...** - You have previously received a drug that works by releasing a toxin from a tubulin-targeting compound (antibody-drug conjugate with tubulin inhibitor payload) - You have active brain metastases that are symptomatic or untreated 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

DRUGDP303c

intravenous injection

DRUGtrastuzumab emtansine

intravenous injection


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06313086


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