Breast Cancer
Conditions
Keywords
Advanced or Metastatic Breast Cancer, Eribulin
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.
Interventions
None listed
Sponsors
Eisai Limited
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with Advanced or Metastatic Breast Cancer on Eribulin for at least 7 months
Exclusion criteria
* Lack of accessible clinical records
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | up to 7 months |
| Progression free survival (PFS) | up to 7 months |
| Objective response rate | up to 7 months |
| Time to response | up to 7 months |
| Post progression survival | up to 7 months |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events/serious adverse events/toxic deaths as a measure of safety | up to 7 months |
Countries
Spain
Outcome results
None listed