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Pyrotinib Plus Vinorelbine in Participants With HER2-positive Previously Treated Locally Advanced or Metastatic Breast Cancer
The purpose of this study is to identify the highest tolerable dose of pyrotinib in combination with vinorelbine and to assess the safety and efficacy of the combination in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer. The study will be conducted in two parts. In the first part, testing will be done on up to 12 subjects to determine the highest tolerable dose of pyrotinib and vinorelbine in patients with advanced solid tumors. In the second part of the study, we will explore the safety and efficacy of Pyrotinib + vinorelbine in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based Therapy. Participants will be treated until disease progression (PD), unmanageable toxicity, or study termination.
Details
| Lead sponsor | Sun Yat-sen University |
|---|---|
| Phase | PHASE2 |
| Status | UNKNOWN |
| Enrolment | 208 |
| Start date | Fri May 22 2020 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Breast Cancer
- Pyrotinib
- Breast Diseases
- Vinorelbine
- HER2-positive Breast Cancer
Interventions
- Pyrotinib 320mg + Vinorelbine
- Pyrotinib 400mg + Vinorelbine
- Pyrotinib plus Vinorelbine
Countries
China