LYNPARZA Breast Cancer in the Adjuvant Setting Japan Post-Marketing Surveillance (PMS)
Active, not recruiting
- Conditions
- Breast Cancer
- Registration Number
- NCT05677308
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
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.
This investigation will be conducted for application for re-examination specified in Article 14-4 of the Pharmaceutical Affairs Law.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 61
Inclusion Criteria
- 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"
Exclusion Criteria
- Patients who have no treatment history with LYNPARZA
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of bone marrow suppression from baseline to 1year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇯🇵Yamanashi, Japan