Clinical trial NCT05677308: LYNPARZA Breast Cancer in the Adjuvant Setting Japan Post-Marketing Surveillance (PMS)
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-01-10
Enrollment: 61
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients who started treatment with LYNPARZA for "Adjuvant treatment for patients with BRCA-mutated HER2 negative high recurrent risk breast cancer"

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.

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.

Eligibility 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

Primary outcomes:
measure: Incidence of bone marrow suppression
timeFrame: from baseline to 1year
Secondary outcomes:
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Research Site
city: Akita
country: Japan
facility: Research Site
city: Aomori
country: Japan
facility: Research Site
city: Chiba
country: Japan
facility: Research Site
city: Ehime
country: Japan
facility: Research Site
city: Fukui
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Gifu
country: Japan
facility: Research Site
city: Gunma
country: Japan
facility: Research Site
city: Hiroshima
country: Japan
facility: Research Site
city: Hokkaido
country: Japan
facility: Research Site
city: Hyogo
country: Japan
facility: Research Site
city: Ibaraki
country: Japan
facility: Research Site
city: Ishikawa
country: Japan
facility: Research Site
city: Iwate
country: Japan
facility: Research Site
city: Kagoshima
country: Japan
facility: Research Site
city: Kanagawa
country: Japan
facility: Research Site
city: Kochi
country: Japan
facility: Research Site
city: Kumamoto
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Mie
country: Japan
facility: Research Site
city: Miyagi
country: Japan
facility: Research Site
city: Nagano
country: Japan
facility: Research Site
city: Nagasaki
country: Japan
facility: Research Site
city: Nara
country: Japan
facility: Research Site
city: Niigata
country: Japan
facility: Research Site
city: Oita
country: Japan
facility: Research Site
city: Okayama
country: Japan
facility: Research Site
city: Okinawa
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Saga
country: Japan
facility: Research Site
city: Saitama
country: Japan
facility: Research Site
city: Shiga
country: Japan
facility: Research Site
city: Shimane
country: Japan
facility: Research Site
city: Shizuoka
country: Japan
facility: Research Site
city: Tochigi
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
city: Tottori
country: Japan
facility: Research Site
city: Toyama
country: Japan
facility: Research Site
city: Wakayama
country: Japan
facility: Research Site
city: Yamaguchi
country: Japan
facility: Research Site
city: Yamanashi
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca KK
name: Toshimitsu Tokimoto
role: STUDY_DIRECTOR
References: