drugset / Trial / NCT04809779
PD-1 Inhibitor Concurrent With Chemotherapy as Neoadjuvant Therapy for TNBC
NaSingle-groupOpen-labelTreatment
Summary
The purpose of the study is to address the following hypotheses: the PD-1 inhibitor Sintilimab 200mg for intravenous (IV) administration will be given together with three-week epirubincin, cyclophosphamide (EC) × 4 treatments from the second cycle followed by weekly nab-paclitaxel x12 treatments or three-week nab-paclitaxel x4 treatments. This regimen will induce higher pathologic complete response (pCR) rate in triple negative breast cancer than historical pCR rates (30-40%) observed with chemotherapy alone.
Timeline
- Start
- 2021-03
- Primary completion
- 2023-12
- Completion
- 2024-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |