drugset / Trial / NCT04900311
Pyrotinib Versus Pertuzumab in Combination With Neoadjuvant Trastuzumab and Nab-Paclitaxel in HER2+ Early or Locally Advanced Breast Cancer
Phase 2
Unknown
490 enrolled
Tianjin Medical University Cancer Institute and Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The study is being conducted to evaluate the efficacy, and safety of pyrotinib versus pertuzumab in combination with trastuzumab and nab-paclitaxel for neoadjuvant treatment in HER2+ early or locally advanced breast cancer patients. To explore whether pyrotinib regimen could provide better clinical results compared with pertuzumab in the study population.
Timeline
- Start
- 2021-05
- Primary completion
- 2023-12
- Completion
- 2025-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pertuzumab | Monoclonal antibody | 420 mg | Intravenous |
| Subject | Pyrotinib | Small molecule | 400 mg | Oral |
| Comparator | Paclitaxel | Small molecule | 125 mg/m2 | Intravenous |
| Comparator | Paclitaxel | Small molecule | 260 mg/m2 | Intravenous |
| Comparator | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |