RecruitingPhase 2NCT07100600

Trastuzumab Rezetecan Combined With Radiotherapy Versus Trastuzumab Rezetecan in the Treatment of HER2-positive Advanced Breast Cancer With Brain Metastases

An Open-label, Randomized, Controlled Trial of Trastuzumab Rezetecan Combined With Radiotherapy Versus Trastuzumab Rezetecan in the Treatment of HER2-positive Advanced Breast Cancer With Brain Metastases


Sponsor

Henan Cancer Hospital

Enrollment

224 participants

Start Date

Aug 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A total of 224 subjects of HER2-positive advanced breast cancer with brain metastases are planned to be enrolled. Eligible subjects will be randomly assigned in a 1:1 ratio to the group receiving Trastuzumab Rezetecan combined with radiotherapy or the group receiving Trastuzumab Rezetecan monotherapy until disease progression, intolerable toxicity, withdrawal of informed consent, or the study determines that treatment must be terminated (whichever occurs first).


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining a targeted antibody-drug therapy called trastuzumab rezetecan with radiation therapy works better than trastuzumab rezetecan alone for women with HER2-positive advanced breast cancer that has spread to the brain. Brain metastases from HER2-positive breast cancer are difficult to treat, and this study aims to find a more effective approach. **You may be eligible if...** - You are a woman aged 18 or older - You have confirmed HER2-positive advanced breast cancer - You have at least one measurable brain tumor that has not yet been treated - You have not received prior brain radiation and do not need immediate local treatment - Your life expectancy is at least 6 months - Your major organ function is adequate **You may NOT be eligible if...** - You have cancer spreading to the membrane around the brain (leptomeningeal metastasis) - You need urgent brain surgery for complications - You have previously been treated with trastuzumab deruxtecan or a similar antibody-drug conjugate - You have uncontrolled heart disease or significant lung disease - You have had another cancer in the past 5 years (with minor exceptions) - 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

DRUGTrastuzumab Rezetecan

Trastuzumab Rezetecan:4.8mg/kg Q3W

RADIATIONFSRT or WBRT

FSRT (8Gy/3-5 fx)or WBRT(30Gy/10fx)


Locations(1)

Professor

Zhengzhou, Henan, China

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NCT07100600


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