Eribulin Use for the Treatment of Advanced Breast Cancer: A Prospective Observational Registry
Completed
- Conditions
- Breast Cancer
- Registration Number
- NCT02443428
- Lead Sponsor
- Eisai Limited
- Brief Summary
The purpose of this prospective observational registry is to monitor safety of eribulin in routine clinical practice. Additionally, this study will also assess the effectiveness of eribulin in real-life settings.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 77
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants with adverse events (AEs) and serious adverse events (SAEs) From date of first administration of study drug up to 30 days after last administration of study drug or until approximately 2 years Safety assessment will consist of monitoring of all AEs, including SAEs at every visit. All participants will be evaluable for safety from the time of their first treatment with eribulin.
- Secondary Outcome Measures
Name Time Method Tumour response From date of enrollment, Day 1 and Day 8 of every 21 day cycle or up to approximately 2 years Overall survival (OS) From date of first administration of study drug to date of death or up to approximately 2 years Demographic and clinical characteristics Up to approximately 2 years Duration of treatment Historical data collected at Baseline Incidence of dose delays From date of first administration up to approximately 2 years Incidence of dose reductions From date of first administration up to approximately 2 years Relative dose intensity (RDI) of eribulin From date of first administration up to approximately 2 years Treatment patterns for locally advanced or metastatic breast cancer Historical data collected at Baseline