A Two-cohort Study of SHR-A1811 in the Treatment of HER2-positive Breast Cancer With Brain Metastases

This is a multi-center, open-label, two-cohort study. The purpose of this study is to evaluate the safety, tolerability and efficacy of SHR-A1811 in the treatment of HER2-positive breast cancer with brain and leptomeningeal metastases, and the efficacy and safety of SHR-A1811 in the treatment of HER2-positive breast cancer with brain but without leptomeningeal metastases.

NCT Number	NCT07177950
Lead Sponsor	Peking University Cancer Hospital & Institute Collaborators: Beijing Tiantan Hospital
Conditions	Breast Cancer, Brain Metastases, Leptomeningeal Metastasis
Enrollment	51 participants
Start Date	2025-09-30
Primary Completion	2028-09-30 (estimated)
Study Completion	2029-09-30 (estimated)
Updated on ClinicalTrials.gov	2025-09-17