Clinical trial · Observational
Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine
Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine in Patients With Previously Treated HER2-Positive Metastatic Breast Cancer: a Multicenter, Retrospective Study
NCT04850625CI-TRIAL-00059483completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Pyrotinib Plus Vinorelbine
- description
- lapatinib (750-1,250 mg/day) plus capecitabine (1,500-2,000 mg/m2)
- label
- Lapatinib Plus Capecitabine
- description
- pyrotinib (320-400 mg/day) plus vinorelbine (25mg/ m2 intravenously or 60 mg/m2 orally on days 1 and 8 per 21 days)
Primary outcomes (1)
- measure
- PFS
- timeFrame
- 6 weeks
- description
- Progression free survival
Secondary outcomes (1)
- measure
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- timeFrame
- 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.