Trials / Completed
CompletedNCT04367090
Pharmacokinetic Study of Pyrotinib and Docetaxel in Combination With Trastuzumab in Patients With HER2 Metastatic Breast Cancer
An Open, Single-arm and Multi-center Pharmacokinetic Study of Pyrotinib and Docetaxel Plus Trastuzumab in Patients With HER2 Positive Recurrent or Metastasis Breast Cancer.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 97 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Docetaxel, trastuzumab | Docetaxel and trastuzumab once per cycle |
| DRUG | Pyrotinib | Pyrotinib 400/320 mg orally daily |
Timeline
- Start date
- 2020-05-28
- Primary completion
- 2022-08-10
- Completion
- 2023-05-24
- First posted
- 2020-04-29
- Last updated
- 2023-09-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04367090. Inclusion in this directory is not an endorsement.