drugset / Trial / NCT07351487
Neoadjuvant Chemotherapy Combined With Sintilimab and Bevacizumab for TNBC (NEOTORCH-BREAST07)
NaSingle-groupOpen-labelTreatment
Summary
This study is a prospective, single arm, multi-center phase II clinical trial. The primary study objective is to evaluate the pathologic complete response（PCR） of treatment of TNBC breast cancer with neoadjuvant chemotherapy combined with Sintilimab and Bevacizumab , including the incidences and types of adverse events. The secondary study objective is to observe and evaluate the event-free survival (EFS), Objective Response Rate(ORR), and radiologic complete response (rCR).
Timeline
- Start
- 2025-09-25
- Primary completion
- 2028-09-25
- Completion
- 2030-09-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 7.5 mg/kg | Intravenous |
| Subject | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 600 mg/m2 | Intravenous |
| Subject | Epirubicin | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 260 mg/m2 | Intravenous |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |