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

StatusRecruiting
PhasePhase 2
Started2025-08-30
View on ClinicalTrials.gov ↗

Amendment history

2025-08-06
minor
Study Status, Conditions, Arms and Interventions v1
Re-verified, no change to tracked fields
2025-07-27
minor
Original filing
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 Number NCT07100600
Lead Sponsor Henan Cancer Hospital
Conditions HER2-positive Advanced Breast Cancer, Brain Metastases, Radiotherapy
Enrollment 224 participants
Start Date 2025-08-30
Primary Completion 2030-07-30 (estimated)
Study Completion 2032-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-08-11