Extended Treatment in Metastatic Breast Cancer With Eribulin
- Conditions
- Breast Cancer
- Registration Number
- NCT02769364
- Lead Sponsor
- Eisai Limited
- Brief Summary
Decision-making for treatment of metastatic breast cancer after the second line of chemotherapy was limited by the lack of established predictive factors of benefit for further chemotherapy regimens. Eribulin has emerged as the only single agent demonstrating an overall survival improvement in the third-line setting or beyond. The purpose of this study was to define the clinical profile of metastatic breast cancer participants achieving long-term benefit from chemotherapy with eribulin in the third-line setting or beyond.
- Detailed Description
This was a multicenter, retrospective, observational, case study analysis to assess long-term eribulin treatment in metastatic breast cancer. The study was conducted in 26 Spanish hospitals participating in a national pre-market access program to eribulin between 2011 and 2014. An exploratory comparison with a group of short-term responders included in a similar observational study was performed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 45
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response rate up to 7 months Post progression survival up to 7 months Progression free survival (PFS) up to 7 months Time to response up to 7 months Overall survival up to 7 months
- Secondary Outcome Measures
Name Time Method Number of participants with adverse events/serious adverse events/toxic deaths as a measure of safety up to 7 months