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Camrelizumab Plus Radiotherapy in Early TNBC
NCT04481763Phase 2
Key facts
- Status
- Recruiting
- Start
- Jul 2020
- Primary completion
- Aug 2024
- Countries
- 1
- Modality
- Immune Checkpoint Inhibitors
- Drugs
- camrelizumab
- Conditions
- triple-negative breast cancer (TNBC)
01
Overview
Phase 2, open-label, single-arm trial of camrelizumab in triple-negative breast cancer (TNBC). Primary endpoint: Invasive Disease-Free Survival at 5 years. Started Jul 2020; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
camrelizumab + radiotherapy
Camrelizumab combined with radiotherapy.
03
Who it enrols
Adult females with early TNBC (ER<1%, PR<1%, HER2-) requiring radiotherapy (e.g., tumor >= 5cm, >=4 LN metastasis). Adequate organ function required. Excludes prior PD-1/PD-L1 therapy, active autoimmune disease, and metastatic disease.
04
Endpoints
Primary
Invasive Disease-Free Survival
Secondary
Overall Survival
Disease-Free Survival
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