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Pyrotinib Plus Trastuzumab and Chemotherapy in HER2+ Metastatic Breast Cancer Patients

Sponsor
Fudan University (Other)
Overall Status
Completed
CT.gov ID
NCT05839288
Collaborator
(none)
161
Enrollment
1
Location
5
Actual Duration (Months)
32.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the patterns and treatment outcomes of pyrotinib plus trastuzumab and chemotherapy in the real world.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    161 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Pyrotinib Plus Trastuzumab and Chemotherapy in Metastatic HER2-positive Breast Cancer Patients- a Multicenter Retrospective Study
    Actual Study Start Date :
    Nov 1, 2022
    Actual Primary Completion Date :
    Mar 1, 2023
    Actual Study Completion Date :
    Apr 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    PyroHC

    Patients used pyrotinib (Pyro) plus trastuzumab (H) and chemotherapy (C) as treatment for metastatic breast cancer.

    Outcome Measures

    Primary Outcome Measures

    1. progression-free survival (PFS) [6 weeks]

      Progression free survival

    Secondary Outcome Measures

    1. Adverse events [6 weeks]

      Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)

    Eligibility Criteria

    Criteria

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

    • woman, age > 18 years old

    • diagnosed with HER2 +Metastatic Breast Cancer

    • received pyrotinib plus trastuzumab and chemotherapy for at least one cycle, starting from 2018.07-2022.09

    • available medical history

    Exclusion Criteria:
    • medical history was incomplete

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Fudan University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biyun Wang, MD, Professor, Fudan University
    ClinicalTrials.gov Identifier:
    NCT05839288
    Other Study ID Numbers:
    • YOUNGBC-26
    First Posted:
    May 3, 2023
    Last Update Posted:
    May 3, 2023
    Last Verified:
    Apr 1, 2023
    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
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of May 3, 2023