drugset / Trial / NCT04809779

PD-1 Inhibitor Concurrent With Chemotherapy as Neoadjuvant Therapy for TNBC

NCT04809779 ↗

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

EvaluationDrugModalityDoseRoute
Subject Sintilimab Monoclonal antibody 200 mg Intravenous