Lynparza Breast Cancer Clinical Experience Investigation

March 15, 2023 updated by: AstraZeneca

Lynparza Tablets 100mg, 150mg CEI, Investigation on Development of Bone Marrow Depression in Patients With Unresectable or Recurrent BRCA Mutated HER2 Negative Breast Cancer Who Have Previously Received Anticancer Chemotherapy

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

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

111

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Aichi, Japan, D0819C00005
        • Research Site
      • Aomori, Japan, D0819C00005
        • Research Site
      • Chiba, Japan, D0819C00005
        • Research Site
      • Ehime, Japan, D0819C00005
        • Research Site
      • Fukui, Japan, D0819C00005
        • Research Site
      • Fukuoka, Japan, D0819C00005
        • Research Site
      • Gunma, Japan, D0819C00005
        • Research Site
      • Hiroshima, Japan, D0819C00005
        • Research Site
      • Hokkaido, Japan, D0819C00005
        • Research Site
      • Hyogo, Japan, D0819C00005
        • Research Site
      • Ibaraki, Japan, D0819C00005
        • Research Site
      • Ishikawa, Japan, D0819C00005
        • Research Site
      • Kagawa, Japan, D0819C00005
        • Research Site
      • Kagoshima, Japan, D0819C00005
        • Research Site
      • Kanagawa, Japan, D0819C00005
        • Research Site
      • Kochi, Japan, D0819C00005
        • Research Site
      • Kyoto, Japan, D0819C00005
        • Research Site
      • Miyagi, Japan, D0819C00005
        • Research Site
      • Nagano, Japan, D0819C00005
        • Research Site
      • Nara, Japan, D0819C00005
        • Research Site
      • Okayama, Japan, D0819C00005
        • Research Site
      • Okinawa, Japan, D0819C00005
        • Research Site
      • Osaka, Japan, D0819C00005
        • Research Site
      • Saitama, Japan, D0819C00005
        • Research Site
      • Shiga, Japan, D0819C00005
        • Research Site
      • Shimane, Japan, D0819C00005
        • Research Site
      • Shizuoka, Japan, D0819C00005
        • Research Site
      • Tokyo, Japan, D0819C00005
        • Research Site
      • Toyama, Japan, D0819C00005
        • Research Site
      • Yamagata, Japan, D0819C00005
        • Research Site
      • Yamaguchi, Japan, D0819C00005
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Investigation sites mainly consisted of department of surgical related department (surgery, mammary gland surgery, and endocrine surgery, etc.) and department of internal medicine.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse drug reactions of bone marrow depression
Time Frame: One year period
Bone marrow depression will be investigated as safety specification topics
One year period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2018

Primary Completion (Actual)

March 24, 2022

Study Completion (Actual)

March 24, 2022

Study Registration Dates

First Submitted

June 27, 2018

First Submitted That Met QC Criteria

July 17, 2018

First Posted (Actual)

July 18, 2018

Study Record Updates

Last Update Posted (Actual)

March 17, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D0819C00005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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