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

NCT ID: NCT05677308

Last Updated: 2025-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-07

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Toshimitsu Tokimoto

Role: STUDY_DIRECTOR

AstraZeneca KK

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Aichi, , Japan

Site Status

Research Site

Akita, , Japan

Site Status

Research Site

Aomori, , Japan

Site Status

Research Site

Chiba, , Japan

Site Status

Research Site

Ehime, , Japan

Site Status

Research Site

Fukui, , Japan

Site Status

Research Site

Fukuoka, , Japan

Site Status

Research Site

Gifu, , Japan

Site Status

Research Site

Gunma, , Japan

Site Status

Research Site

Hiroshima, , Japan

Site Status

Research Site

Hokkaido, , Japan

Site Status

Research Site

Hyōgo, , Japan

Site Status

Research Site

Ibaraki, , Japan

Site Status

Research Site

Ishikawa, , Japan

Site Status

Research Site

Kanagawa, , Japan

Site Status

Research Site

Kochi, , Japan

Site Status

Research Site

Kumamoto, , Japan

Site Status

Research Site

Kyoto, , Japan

Site Status

Research Site

Mie, , Japan

Site Status

Research Site

Miyagi, , Japan

Site Status

Research Site

Nara, , Japan

Site Status

Research Site

Niigata, , Japan

Site Status

Research Site

Numakunai, , Japan

Site Status

Research Site

Okayama, , Japan

Site Status

Research Site

Okinawa, , Japan

Site Status

Research Site

Osaka, , Japan

Site Status

Research Site

Ōita, , Japan

Site Status

Research Site

Saga, , Japan

Site Status

Research Site

Saitama, , Japan

Site Status

Research Site

Shiga, , Japan

Site Status

Research Site

Shimane, , Japan

Site Status

Research Site

Shizuoka, , Japan

Site Status

Research Site

Tochigi, , Japan

Site Status

Research Site

Tokyo, , Japan

Site Status

Research Site

Tottori, , Japan

Site Status

Research Site

Toyama, , Japan

Site Status

Research Site

Wakayama, , Japan

Site Status

Research Site

Yamaguchi, , Japan

Site Status

Research Site

Yamanashi, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D081CC00012

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.