drugset / Trial / NCT05430347
Clinical Study of Pyrotinib in Neoadjuvant Therapy of HR-positive and HER2-positive Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
Due to neoadjuvant therapy with trastuzumab and pertuzumab is less effective for HR+/HER2+ breast cancer, and the PHEDRA Clinical Study subgroup analysis showed that the addition of pyrotinib to trastuzumab more than doubled pCR rates in HR+/HER2+ patients. our research group proposed a hypothesis that pyrotinib may be more advantageous for HR+/HER2+ breast cancer. Therefore, our center intends to carry out a multi-center, randomized controlled, prospective clinical study to compare the efficacy of pyrotinib or pertuzumab combined with docetaxel, carboplatin and trastuzumab in neoadjuvant therapy for patients with HR+/HER2+ breast cancer, and to conduct a comparative study on the safety.
Timeline
- Start
- 2023-04-15
- Primary completion
- 2025-06-15
- Completion
- 2025-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pertuzumab | Monoclonal antibody | 420 mg | — |
| Subject | Pyrotinib | Small molecule | 400 mg | — |
| Background | Carboplatin | Small molecule | 6 unknown | — |
| Background | Docetaxel | Small molecule | 100 mg/m2 | — |
| Background | Trastuzumab | Monoclonal antibody | 6 mg/kg | — |