RecruitingNot ApplicableNCT05831878

RC48-ADC in HER2-low Advanced Breast Cancer

Disitamab Vedotin (RC48-ADC) in Patients With HER2-low Advanced Breast Cancer


Sponsor

RenJi Hospital

Enrollment

36 participants

Start Date

May 4, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the efficacy and safety of Disitamab vedotin (RC48-ADC) as salvage treatment in patients with HER2-low advanced breast cancer who have received up to one previous chemotherapy for recurrent or metastatic disease without previous use of antibody-drug conjugate.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a targeted drug called RC48-ADC in women with advanced or metastatic breast cancer that has low or very low levels of a protein called HER2. Unlike standard HER2-positive breast cancer treatments, this trial focuses on patients whose tumors have only a trace amount of HER2. The goal is to see if this drug can slow or stop cancer growth. **You may be eligible if...** - You are a woman aged 18 or older with advanced or metastatic breast cancer - Your cancer has low or very low HER2 levels (confirmed by a test) - You have not previously received an antibody-drug conjugate treatment - You have had at most one prior chemotherapy for advanced disease - Your general health is good (ECOG score of 0 or 1) **You may NOT be eligible if...** - You have had a blood clot (thromboembolism) in the past - You have uncontrolled conditions like diabetes, high blood pressure, or lung disease - You have active infections needing treatment - You are pregnant or breastfeeding - Your cancer has spread to the brain 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

DRUGDisitamab vedotin

2.0mg/kg, iv, day1, every 2 weeks


Locations(1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, China

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NCT05831878


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