Trial Title:
LYNPARZA Breast Cancer in the Adjuvant Setting Japan Post-Marketing Surveillance (PMS)
NCT ID:
NCT05677308
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
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.
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.
Criteria for eligibility:
Study pop:
The patients who started treatment with LYNPARZA for "Adjuvant treatment for patients
with BRCA-mutated HER2 negative high recurrent risk breast cancer"
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Aichi
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Akita
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Aomori
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Chiba
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Ehime
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Fukui
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Fukuoka
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Gifu
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Gunma
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Hiroshima
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Hokkaido
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Hyogo
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Ibaraki
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Ishikawa
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Iwate
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Kagoshima
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Kanagawa
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Kochi
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Kumamoto
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Kyoto
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Mie
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Miyagi
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Nagano
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Nagasaki
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Nara
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Niigata
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Oita
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Okayama
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Okinawa
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Osaka
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Saga
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Saitama
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Shiga
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Shimane
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Shizuoka
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Tochigi
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Tokyo
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Tottori
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Toyama
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Wakayama
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Yamaguchi
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Yamanashi
Country:
Japan
Start date:
March 7, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05677308
