Breast Cancer Clinical Trial
Official title:
Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine in Patients With Previously Treated HER2-Positive Metastatic Breast Cancer: a Multicenter, Retrospective Study
| NCT number | NCT04850625 |
| Other study ID # | YOUNGBC-14 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 15, 2020 |
| Est. completion date | June 15, 2021 |
| Verified date | June 2022 |
| Source | Fudan University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine
| Status | Completed |
| Enrollment | 224 |
| Est. completion date | June 15, 2021 |
| Est. primary completion date | June 15, 2021 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Fudan University Shanghai Cancer Center | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Fudan University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | PFS | Progression free survival | 6 weeks | |
| Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 6 weeks |
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