Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine
Completed
- Conditions
- Breast Cancer
- Registration Number
- NCT04850625
- Lead Sponsor
- Fudan University
- Brief Summary
Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine
- Detailed Description
This is a retrospective study aiming to explore the efficacy and safety of Pyrotinib plus Vinorelbine versus Lapatinib plus Capecitabine in patients with previously treated HER2-positive metastatic breast cancer.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 224
Inclusion Criteria
- HER2+ MBC patients scored +3 by immunohistochemical (IHC) analysis or scored +2 and the result of fluorescence in situ hybridization was positive.
- Patients were previously treated with trastuzumab in the advanced setting and a taxane in any setting.
- Patients received lapatinib (750-1,250 mg/day) plus capecitabine (1,500-2,000 mg/m2) or pyrotinib (320-400 mg/day) plus vinorelbine (25mg/ m2 intravenously or 60 mg/m2 orally on days 1 and 8 per 21 days) for at least one cycle, starting from Jun 2015 to Jan 2021.
- Patients had complete medical records. All data were retrospectively collected from medical records of individual institutions.
Exclusion Criteria
- Incomplete medical history
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PFS 6 weeks Progression free survival
- Secondary Outcome Measures
Name Time Method Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 6 weeks
Trial Locations
- Locations (1)
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, China