drugset / Trial / NCT04613674

A Study of Camrelizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)

NCT04613674

Phase 3 Completed 441 enrolled Jiangsu HengRui Medicine Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of camrelizumab (an engineered anti-programmed death-ligand 1 \[PD-1\] antibody) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy in participants with triple negative breast cancer (TNBC). Participants will be randomized in a 1:1 ratio to Arm A (camrelizumab +chemotherapy) or Arm B (placebo + chemotherapy).

Timeline

Start
2020-12-09
Primary completion
2023-09-14
Completion
2024-03-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Camrelizumab Monoclonal antibody 200 mg
Background Carboplatin Small molecule 1.5 unknown
Background Cyclophosphamide Other / unclassified 500 mg/m2
Background Epirubicin Small molecule 90 mg/m2
Background Paclitaxel Small molecule 100 mg/m2