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Famitinib Combined With SHR-A1811 Versus SHR-A1811 for Advanced Breast Cancer
NCT07382687Phase 3
Key facts
- Status
- Not yet recruiting
- Start
- Feb 2026
- Primary completion
- Dec 2028
- Countries
- 1
- Sponsor
- Fudan University
- Modality
- Small Molecules
- Drugs
- famitinib
- Conditions
- breast cancer
01
Overview
Phase 3, randomised, open-label trial of famitinib in breast cancer (2 arms), sponsored by Fudan University. Primary endpoint: Progression Free Survival at 3 years. Planned start Feb 2026; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
SHR-A1811
SHR-A1811 4.8mg/kg iv q3w
Famitinib + SHR-A1811
Famitinib 10mg po qd + SHR-A1811 4.8mg/kg iv q3w
03
Who it enrols
Women aged 18-70 with HR+/HER2- advanced breast cancer (SNF4 subtype) who have progressed on or after CDK4/6 inhibitors, with adequate organ function and ECOG <= 2.
04
Endpoints
Primary
Progression Free Survival
Secondary
Overall Survival
Objective Response Rate
Clinical Benefit Rate
Duration of Response
Time to Response
Treatment-Emergent Adverse Events
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