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Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine

Sponsor
Fudan University (Other)
Overall Status
Completed
CT.gov ID
NCT04850625
Collaborator
(none)
224
Enrollment
1
Location
17
Actual Duration (Months)
13.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    224 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine in Patients With Previously Treated HER2-Positive Metastatic Breast Cancer: a Multicenter, Retrospective Study
    Actual Study Start Date :
    Jan 15, 2020
    Actual Primary Completion Date :
    Jun 15, 2021
    Actual Study Completion Date :
    Jun 15, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Pyrotinib Plus Vinorelbine

    lapatinib (750-1,250 mg/day) plus capecitabine (1,500-2,000 mg/m2)
    Lapatinib Plus Capecitabine

    pyrotinib (320-400 mg/day) plus vinorelbine (25mg/ m2 intravenously or 60 mg/m2 orally on days 1 and 8 per 21 days)

    Outcome Measures

    Primary Outcome Measures

    1. PFS [6 weeks]

      Progression free survival

    Secondary Outcome Measures

    1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [6 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fudan University Shanghai Cancer Center Shanghai China 200032

    Sponsors and Collaborators

    • Fudan University

    Investigators

    • Principal Investigator: Biyun Wang, Professor, Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biyun Wang, MD, Professor, Fudan University
    ClinicalTrials.gov Identifier:
    NCT04850625
    Other Study ID Numbers:
    • YOUNGBC-14
    First Posted:
    Apr 20, 2021
    Last Update Posted:
    Jul 5, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Biyun Wang, MD, Professor, Fudan University
    Pyrotinib
    Lapatinib
    Vinorelbine
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Jul 5, 2022