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

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).

Trial Details

NCT ID

NCT07100600

Phase

PHASE2

Sponsor

Henan Cancer Hospital

Status

RECRUITING

Cancer Type

Breast Cancer

Interventions

Trastuzumab Rezetecan
FSRT or WBRT

Locations (sample)

Zhengzhou, Henan, China|34.75778,113.64861

Key Eligibility Criteria

Females ≥18 yrs old;
Pathologically confirmed HER2-positive advanced breast cancer;
At least one measurable intracranial lesion according to RANO-BM criteria, which had not received local treatment;
Without prior cranial radiation and had no indication for immediate local treatment or refuse to local treatment;

For full eligibility, visit ClinicalTrials.gov.

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