drugset / Trial / NCT04613674
A Study of Camrelizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |