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.
Women aged 18-75 years (inclusive).
Histologically or cytologically confirmed HER2-positive advanced breast cancer (IHC 3+, or IHC 2+ with ISH amplification).
Cohort A (leptomeningeal metastasis cohort): leptomeningeal involvement demonstrated by contrast-enhanced MRI or positive cerebrospinal fluid (CSF) cytology.
Cohort B (no leptomeningeal metastasis cohort): ≥1 measurable intracranial lesion; either CNS-naïve or progressive after prior local therapy.
Cerebrospinal fluid (CSF) circulation obstruction that cannot be adequately controlled by therapeutic measures.
MRI evidence of nodular leptomeningeal (LM) disease in the setting of negative CSF cytology.
Active central nervous system (CNS) infection.
Clinically significant coagulopathy.
Peking University Cancer Hospital & Institute
Lead sponsor
Beijing Tiantan Hospital
Collaborator