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FS-1502 vs T-DM1 in HER2-positive Advanced Breast Cancer
NCT05755048Phase 3
Key facts
- Status
- Recruiting
- Start
- Mar 2023
- Primary completion
- Jul 2025
- Countries
- 1
- Sponsor
- Fosun Pharma
- Modality
- Monoclonal Antibodies, Antibody-Drug Conjugates (ADCs)
- Conditions
- breast cancer
01
Overview
Phase 3, randomised, open-label trial of caxmotabart entudotin in breast cancer (2 arms), sponsored by Fosun Pharma. Primary endpoint: Progression-Free Survival at 28 months. Started Mar 2023; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
FS-1502
FS-1502 2.3 mg/kg IV every 3 weeks
T-DM1
Trastuzumab emtansine 3.6 mg/kg IV every 3 weeks
03
Who it enrols
Patients with HER2-positive locally advanced or metastatic breast cancer who have received prior trastuzumab and taxane therapy, with 1-3 prior lines of treatment for metastatic disease.
04
Endpoints
Primary
Progression-Free Survival
Secondary
Overall Survival
Objective Response Rate
Disease Control Rate
Clinical Benefit Rate
Duration of Response
Treatment-Emergent Adverse Events
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