RecruitingPhase 2NCT04303988

A Phase II Study of Triple-negative Breast Cancer Brain Metastases.

A Prospective, Single-arm, Single-center, Phase II Clinical Study of Triple-negative Breast Cancer Brain Metastases


Sponsor

Fudan University

Enrollment

35 participants

Start Date

Mar 30, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

Study to assess the effectiveness and safety of SHR 1316, bevacizumab combined with cisplatin/carboplatin for treatment of triple-negative breast cancer brain metastases.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a combination of a chemotherapy drug and an immunotherapy drug can treat triple-negative breast cancer (TNBC) that has spread to the brain — a type of cancer with very few treatment options. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with triple-negative breast cancer (hormone receptor-negative and HER2-negative) - Your cancer has spread or come back and cannot be removed with surgery or treated with radiation - You have brain metastases (cancer that has spread to the brain) - You are in reasonably good health (ECOG performance status 0-2) - You have not previously used platinum-based chemotherapy, or if you have, your cancer responded to it for at least 3 months **You may NOT be eligible if...** - You have HER2-positive or hormone receptor-positive breast cancer - Your cancer did not respond to prior platinum-based chemotherapy - You are pregnant or breastfeeding - Your organ function does not meet minimum requirements 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

DRUGSHR-1316

IV

DRUGBevacizumab

IV

DRUGCisplatin/Carboplatin

IV


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT04303988


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