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RECRUITING
NCT07100600
PHASE2

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

Sponsor: Henan Cancer Hospital

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

224

Start Date

2025-08-30

Completion Date

2032-12-30

Last Updated

2025-08-11

Healthy Volunteers

No

Interventions

DRUG

Trastuzumab Rezetecan

Trastuzumab Rezetecan:4.8mg/kg Q3W

RADIATION

FSRT or WBRT

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

Locations (1)

Professor

Zhengzhou, Henan, China