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Completed

NCT Number: NCT03590938

Lynparza Breast Cancer Clinical Experience Investigation

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Aichi, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Adverse drug reactions of bone marrow depression

    Time frame: One year period

    Bone marrow depression will be investigated as safety specification topics

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jul 18, 2018
Registry last updated
Mar 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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