drugset / Trial / NCT04367090
Pharmacokinetic Study of Pyrotinib and Docetaxel in Combination With Trastuzumab in Patients With HER2 Metastatic Breast Cancer
NaSingle-groupOpen-labelTreatment
Summary
The primary objective of the study is to study the pharmacokinetics of pyrotinib and docetaxel plus Trastuzumab in HER2 Positive MBC. The secondary objective of the study is to evaluate the safety and efficacy (ORR) of pyrotinib and docetaxel plus Trastuzumab in HER2 Positive MBC.
Timeline
- Start
- 2020-05-28
- Primary completion
- 2022-08-10
- Completion
- 2023-05-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | — | — |
| Subject | Pyrotinib | Small molecule | 320 mg | Oral |
| Subject | Pyrotinib | Small molecule | 400 mg | Oral |
| Subject | Trastuzumab | Monoclonal antibody | — | — |