NCT05677308

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

38 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 7, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2026

Completed
Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

January 9, 2023

Last Update Submit

March 12, 2026

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Incidence of bone marrow suppression

    from baseline to 1year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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"

You may qualify if:

  • 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"

You may not qualify if:

  • Patients who have no treatment history with LYNPARZA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (38)

Research Site

Aichi, Japan

Location

Research Site

Akita, Japan

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Aomori, Japan

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Chiba, Japan

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Ehime, Japan

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Fukui, Japan

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Fukuoka, Japan

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Gifu, Japan

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Gunma, Japan

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Hiroshima, Japan

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Hokkaido, Japan

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Hyōgo, Japan

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Ibaraki, Japan

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Ishikawa, Japan

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Kanagawa, Japan

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Kochi, Japan

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Kumamoto, Japan

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Kyoto, Japan

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Mie, Japan

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Miyagi, Japan

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Nara, Japan

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Niigata, Japan

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Numakunai, Japan

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Okayama, Japan

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Okinawa, Japan

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Osaka, Japan

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Ōita, Japan

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Saga, Japan

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Saitama, Japan

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Shiga, Japan

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Shimane, Japan

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Shizuoka, Japan

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Tochigi, Japan

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Tokyo, Japan

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Tottori, Japan

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Toyama, Japan

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Wakayama, Japan

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Yamaguchi, Japan

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Toshimitsu Tokimoto

    AstraZeneca KK

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2023

First Posted

January 10, 2023

Study Start

March 7, 2023

Primary Completion

February 18, 2026

Study Completion

February 18, 2026

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
More information

Locations

JP(38)