A Prospective, Open, Multicenter Single-arm Clinical Studie of Docetaxel, Carboplatin Combined With Inetetamab and Pyrotinib in the Treatment of Local-advanced HER2-positive Breast Cancer
Summary
This study is a prospective, open, multi-center, single arm trial. The treatment group will receive six cycles of docetaxel, carboplatin combined with Inetetamab and Pyrotinib before surgery. By focusing on tpCR (ypT0/is, ypN0) evaluated by pathology, the efficacy of docetaxel, carboplatin combined with Inetetamab and Pyrotinib in the preoperative treatment of locally advanced HER2-positive breast cancer will be evaluated. During long-term follow-up, event-free survival (EFS), disease-free survival (DFS), distant metastasis-free survival (DDFS), overall survival (OS), central nervous system disease-free survival (CNSDFS) under this treatment regimen will be evaluated, and the efficacy-related biomarkers will be explored. The cardiotoxicity of Inetetamab and Pyrotinib in the treatment of breast cancer is also be evaluated.
Timeline
- Start
- 2021-11-27
- Primary completion
- 2025-07-31
- Completion
- 2031-08-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | — | Intravenous |
| Subject | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Docetaxel | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Inetetamab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | Pyrotinib | Small molecule | 400 mg | Oral |