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Phase II Study of SHR-A1811 for Ultra-Low HER2 Advanced Breast Cancer

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
This is a single-center, single-arm, open-label phase II exploratory study. A total of 30 patients aged 18-75 years with ECOG PS 0-1, pathologically confirmed advanced breast cancer with ultra-low HER2 expression will be enrolled. Eligible patients must have at least one measurable lesion and have received 1-2 lines of prior systemic therapy for advanced disease. All participants receive intravenous SHR-A1811 at 4.8 mg/kg every 3 weeks, until disease progression, intolerable adverse events or other discontinuation criteria. The primary endpoint is objective response rate (ORR). Secondary endpoints include progression-free survival (PFS), overall survival (OS), duration of response (DOR), disease control rate (DCR), clinical benefit rate (CBR), and safety profile.
Trial Details
NCT Number NCT07817082
Lead Sponsor Tianjin Medical University Cancer Institute and Hospital
Conditions
(from sponsor)		 Advanced Breast Cancer With Ultra-Low HER2 Expression
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov