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LYNPARZA Breast Cancer in the Adjuvant Setting Japan Post-Marketing Surveillance (PMS)

Sponsor
AstraZeneca (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05677308
Collaborator
(none)
104
Enrollment
46.8
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

To evaluate the frequency of bone marrow suppression Adverse Drug Reactions (ADRs) in patients with BRCA mutated HER2 negative high recurrent risk breast cancer treated with LYNPARZA for adjuvant treatment in the actual post-marketing use.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    To evaluate the frequency of bone marrow suppression Adverse Drug Reactions (ADRs) in patients with BRCA mutated HER2 negative high recurrent risk breast cancer treated with LYNPARZA for adjuvant treatment in the actual post-marketing use.

    This investigation will be conducted for application for re-examination specified in Article 14-4 of the Pharmaceutical Affairs Law.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    104 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    LYNPARZA Tablets 100mg, 150mg General Drug Use-results Study in Patients With BRCA Mutated HER2 Negative High Recurrent Risk Breast Cancer in the Adjuvant Setting
    Anticipated Study Start Date :
    Jan 20, 2023
    Anticipated Primary Completion Date :
    Dec 14, 2026
    Anticipated Study Completion Date :
    Dec 14, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of bone marrow suppression [from baseline to 1year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • The patients who started treatment with LYNPARZA for the first time for the approved indication "Adjuvant treatment for patients with BRCA-mutated HER2 negative high recurrent risk breast cancer"
    Exclusion Criteria:
    • Patients who have no treatment history with LYNPARZA

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Director: Toshimitsu Tokimoto, AstraZeneca KK

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT05677308
    Other Study ID Numbers:
    • D081CC00012
    First Posted:
    Jan 10, 2023
    Last Update Posted:
    Jan 10, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Jan 10, 2023