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NCT05677308 Clinical Trial

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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05677308
Other study ID # D081CC00012
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 7, 2023
Est. completion date December 31, 2026

Study information
Verified date May 2024
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email information.center@astrazeneca.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 104
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Research Site Aichi
Japan Research Site Aichi
Japan Research Site Akita
Japan Research Site Akita
Japan Research Site Aomori
Japan Research Site Chiba
Japan Research Site Chiba
Japan Research Site Ehime
Japan Research Site Fukui
Japan Research Site Fukui
Japan Research Site Fukuoka
Japan Research Site Fukuoka
Japan Research Site Gifu
Japan Research Site Gifu
Japan Research Site Gunma
Japan Research Site Gunma
Japan Research Site Hiroshima
Japan Research Site Hiroshima
Japan Research Site Hokkaido
Japan Research Site Hokkaido
Japan Research Site Hyogo
Japan Research Site Ibaraki
Japan Research Site Ishikawa
Japan Research Site Iwate
Japan Research Site Kagoshima
Japan Research Site Kanagawa
Japan Research Site Kanagawa
Japan Research Site Kochi
Japan Research Site Kochi
Japan Research Site Kumamoto
Japan Research Site Kyoto
Japan Research Site Kyoto
Japan Research Site Mie
Japan Research Site Miyagi
Japan Research Site Miyagi
Japan Research Site Nagano
Japan Research Site Nagasaki
Japan Research Site Nara
Japan Research Site Nara
Japan Research Site Niigata
Japan Research Site Oita
Japan Research Site Okayama
Japan Research Site Okayama
Japan Research Site Okinawa
Japan Research Site Osaka
Japan Research Site Osaka
Japan Research Site Saga
Japan Research Site Saitama
Japan Research Site Saitama
Japan Research Site Shiga
Japan Research Site Shiga
Japan Research Site Shimane
Japan Research Site Shizuoka
Japan Research Site Shizuoka
Japan Research Site Tochigi
Japan Research Site Tokyo
Japan Research Site Tokyo
Japan Research Site Tokyo
Japan Research Site Tottori
Japan Research Site Toyama
Japan Research Site Toyama
Japan Research Site Wakayama
Japan Research Site Yamaguchi
Japan Research Site Yamanashi

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of bone marrow suppression from baseline to 1year
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