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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05677308

Enrollment

Registered

2023-01-10

Start date

2023-03-07

Completion date

2026-02-18

Last updated

2026-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of bone marrow suppression	from baseline to 1year

Countries

Japan

Contacts

STUDY_DIRECTORToshimitsu Tokimoto

AstraZeneca KK

Outcome results