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NCT04850625 Clinical Trial

Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine

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

Clinical Trial Details — Status: Completed

Administrative data
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

Study information
Verified date June 2022
Source Fudan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine

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 information / eligibility
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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Fudan University Shanghai Cancer Center Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome
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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