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).
Conditions studied
HER2-positive Advanced Breast Cancer, Brain Metastases, Radiotherapy
About this study
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).
Interventions
- Drug: Trastuzumab Rezetecan — Trastuzumab Rezetecan:4.8mg/kg Q3W
- Radiation: FSRT or WBRT — FSRT (8Gy/3-5 fx)or WBRT(30Gy/10fx)
Primary outcomes
- PFS (up to 1.5 years)
Eligibility information
Study locations
- Professor, Zhengzhou, Henan China
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-21.