drugset / Trial / NCT04717531
Pyrotinib as Neoadjuvant Agent for Non-objective Response HER2-positive Early Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The study assesses the efficacy of neoadjuvant treatment with pyrotinib and trastuzumab with chemotherapy, mainly pathological complete response (pCR) rates in the breast and axilla. And also assesses side effects, event-free survival (EFS), disease-free survival (DFS), distant disease-free survival (DDFS), and objective response rates (ORR).
Timeline
- Start
- 2021-06-03
- Primary completion
- 2023-06-01
- Completion
- 2024-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pertuzumab | Monoclonal antibody | 420 mg | — |
| Subject | Pyrotinib | Small molecule | 400 mg | Oral |
| Background | Cyclophosphamide | Other / unclassified | 600 mg/m2 | — |
| Background | Docetaxel | Small molecule | 100 mg/m2 | — |
| Background | Epirubicin | Small molecule | 90 mg/m2 | — |
| Background | Trastuzumab | Monoclonal antibody | 6 mg/kg | — |