Lynparza Breast Cancer Clinical Experience Investigation

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03590938

Enrollment

111

Registered

2018-07-18

Start date

2018-08-14

Completion date

2022-03-24

Last updated

2023-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Japan

Outcome results