Trials / Unknown
UnknownNCT03863223
A Study of Pyrotinib in Combination With Trastuzumab and Docetaxel in Patients With HER2 Metastatic Breast Cancer
A Phase 3,Randomized, Double-blinded, Placebo-controlled Study to Evaluate Efficacy and Safety of Pyrotinib Plus Trastuzumab and Docetaxel Versus Placebo Plus Trastuzumab and Docetaxel in Patients With HER2 Positive MBC.
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 590 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, double-blinded, multicenter phase 3 clinical trial to evaluate the efficacy and safety of pyrotinib plus trastuzumab plus docetaxel versus placebo plus trastuzumab plus docetaxel in patients who have HER2 positive metastatic breast cancer and have not received systemic anticancer therapy for advanced disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pyrotinib, Trastuzumab, Docetaxel | Pyrotinib 400mg orally daily until progressive disease |
| DRUG | Placebo, Trastuzumab, Docetaxel | Placebo 400mg orally daily until progressive disease |
Timeline
- Start date
- 2019-04-22
- Primary completion
- 2022-12-30
- Completion
- 2024-07-30
- First posted
- 2019-03-05
- Last updated
- 2022-11-23
Locations
1 site across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03863223. Inclusion in this directory is not an endorsement.