drugset / Trial / NCT03756064
Neoadjuvant Study of Pyrotinib in Patients With HER2 Positive Breast Cancer
RandomizedParallel-groupTriple-blindTreatment
Summary
This is a randomized, double-blind multicenter Phase III study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel and Carboplatin versus placebo and trastuzumab plus docetaxel and Carboplatin given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.
Timeline
- Start
- 2019-08-01
- Primary completion
- 2020-07-31
- Completion
- 2021-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pyrotinib | Small molecule | 400 mg | Oral |
| Background | Carboplatin | Small molecule | 5 unknown | — |
| Background | Docetaxel | Small molecule | 75 mg/m2 | — |
| Background | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |