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Pembrolizumab Plus Fulvestrant in HR+/HER2- Advanced/Metastatic Breast Cancer
NCT03393845Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Jan 2018
- Primary completion
- Aug 2023
- Countries
- 1
- Sponsor
- Nancy Chan
- Modality
- Immune Checkpoint Inhibitors, Recombinant Proteins and Enzymes
- Drugs
- pembrolizumab
- Conditions
- breast cancer
01
Overview
Phase 2, open-label, single-arm trial of pembrolizumab in breast cancer, sponsored by Nancy Chan. Primary endpoint: Clinical Benefit Ratio at 36 months. Started Jan 2018; status: active, not recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Pembrolizumab + Fulvestrant
Experimental arm receiving pembrolizumab and fulvestrant combination therapy.
03
Who it enrols
Adults with metastatic HR+/HER2- breast cancer, ECOG PS 0-1, up to 2 prior lines of therapy, measurable disease, and adequate organ function.
04
Endpoints
Primary
Clinical Benefit Ratio
Secondary
Safety profile
Progression-Free Survival
Durable Response Rate
Overall Survival
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