The purpose of this study was to evaluate the efficacy and safety of eribulin in standard clinical practice in patients with locally recurrent or metastatic advanced breast cancer.
This was an observational, cross-sectional, retrospective, multicenter study conducted in Spain. During the year after authorization of the drug by the European Medicines Agency (EMA), patients in the compassionate use program (public sites) and patients treated in private sites (no purchase restrictions) who received at least 1 dose of treatment with eribulin per approved label at any of the 17 Spanish sites with the highest numbers of treated cases during that period (minimum 3 patients/site) were enrolled in this observational study. Approximately 112 patients will be enrolled in the study.
Study Type
OBSERVATIONAL
Enrollment
112
Hospital Comarcal de Barbastro
Huesca, Spain
Complejo Hospitalario de Jaen
Jaén, Spain
Hospital Arnau de Vilanova
Lleida, Spain
Clinical benefit rate
Time frame: From signing of informed consent up to 1 year
Objective response rate
Time frame: From signing of informed consent up to 1 year
Overall survival
Time frame: From signing of informed consent up to 1 year
Progression-free survival
Time frame: From signing of informed consent up to 1 year
Change from baseline in tumor markers CA15-3
Time frame: Baseline and up to 1 year
Time to response from start of treatment
Time frame: From signing of informed consent up to 1 year
Duration of response
Time frame: From signing of informed consent up to 1 year
Duration of stabilization
Time frame: From signing of informed consent up to 1 year
Post-treatment survival
Time frame: From signing of informed consent up to 1 year
Progression time after interruption
Time frame: From signing of informed consent up to 1 year
Number of patients with adverse events / serious adverse events
Time frame: From signing of informed consent up to 1 year
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Clínica Román
Madrid, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Madrid Norte Sanchinarro
Madrid, Spain
Hospital MD Anderson
Madrid, Spain
Hospital Quirón Madrid
Madrid, Spain
Hospital Sanitas La Moraleja
Madrid, Spain
...and 7 more locations