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Lynparza Breast Cancer Clinical Experience Investigation

NCT ID: NCT03590938

Last Updated: 2023-03-17

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

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Recruitment Status

COMPLETED

Total Enrollment

111 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-14

Study Completion Date

2022-03-24

Brief Summary

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To characterise the development of ADRs of bone marrow depression in patients under actual post-marketing use

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Detailed Description

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To characterise the development of adverse drug reactions (ADRs) of bone marrow depression in patients with unresectable or recurrent BRCA mutated HER2 negative breast cancer who have previously received anticancer chemotherapy under actual post-marketing use.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Unresectable or recurrent BRCA mutated HER2 negative breast cancer with prior anticancer chemotherapy

Exclusion Criteria

* The patients who are not started on Lymparza for the first time
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Toshimitsu Tokimoto

Role: STUDY_DIRECTOR

AstraZeneca KK

Locations

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Research Site

Aichi, , Japan

Site Status

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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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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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Kagawa, , Japan

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Kagoshima, , Japan

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Kanagawa, , Japan

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Kochi, , Japan

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Kyoto, , Japan

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Miyagi, , Japan

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Nagano, , Japan

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Nara, , Japan

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Okayama, , Japan

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Okinawa, , Japan

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Osaka, , 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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Tokyo, , Japan

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Toyama, , Japan

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Yamagata, , Japan

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Yamaguchi, , Japan

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Countries

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Japan

Related Links

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https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D0819C00005&attachmentIdentifier=d8a01299-bcfa-4ad7-9c00-c66ca8ff52d6&fileName=D0819C00005-Synopsis.pdf&versionIdentifier=

Related Info

Other Identifiers

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D0819C00005

Identifier Type: -

Identifier Source: org_study_id

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