drugset / Trial / NCT07100600

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

NCT07100600

Phase 2 Recruiting 224 enrolled Henan Cancer Hospital
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2025-08-30
Primary completion
2030-07-30
Completion
2032-12-30

Drugs

EvaluationDrugModalityDoseRoute
Background Trastuzumab Rezetecan Monoclonal antibody 4.8 mg/kg