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SHR-A1811 in HER2-positive Breast Cancer with Brain/Leptomeningeal Metastases
NCT07177950Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Sep 2025
- Primary completion
- Sep 2028
- Sponsor
- Peking University Cancer Hospital & Institute
- Modality
- Monoclonal Antibodies, Antibody-Drug Conjugates (ADCs), Small Molecules
- Conditions
- HER2-positive breast cancer
01
Overview
Phase 2, open-label trial of trastuzumab rezetecan in HER2-positive breast cancer (2 cohorts), sponsored by Peking University Cancer Hospital & Institute. Primary endpoints: Number of Dose-Limiting Toxicities at 3 weeks and Central Nervous System Progression-Free Survival at 2 years. Planned start Sep 2025; status: not yet recruiting.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Cohort A (LM+)
Systemic SHR-A1811 + Intrathecal SHR-A1811
Cohort B (LM-)
Systemic SHR-A1811 + Radiotherapy
03
Who it enrols
Women with HER2-positive advanced breast cancer and brain metastases (with or without leptomeningeal disease), adequate organ function, and no prior exposure to topoisomerase I inhibitor ADCs.
04
Endpoints
Primary
Number of Dose-Limiting Toxicities
Central Nervous System Progression-Free Survival
Secondary
Central Nervous System Progression-Free Survival
Central Nervous System Objective Response Rate
Progression-Free Survival
Overall Survival
Quality of Life Score
Incidence and Severity of Adverse Events and Serious Adverse Events
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