Eribulin [Halaven] Use For the Treatment of Advanced Breast Cancer

Completed

• Conditions: Metastatic Breast Cancer

• Registration Number: NCT02790320
• Lead Sponsor: Eisai Farmacêutica S.A.

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2012-06
• Primary Completion: 2012-10
• Study Completion: 2012-11
• Status Verified: 2016-04
• Study First Submitted: 2016-05-31
• Study First Submitted QC: 2016-06-02
• Last Update Submitted: 2016-06-02
• Study First Posted: 2016-06-03
• Last Update Posted: 2016-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical benefit rate	From signing of informed consent up to 1 year

Secondary Outcome Measures

Name	Time	Method
Duration of response	From signing of informed consent up to 1 year
Objective response rate	From signing of informed consent up to 1 year
Overall survival	From signing of informed consent up to 1 year
Duration of stabilization	From signing of informed consent up to 1 year
Post-treatment survival	From signing of informed consent up to 1 year
Progression-free survival	From signing of informed consent up to 1 year
Change from baseline in tumor markers CA15-3	Baseline and up to 1 year
Time to response from start of treatment	From signing of informed consent up to 1 year
Number of patients with adverse events / serious adverse events	From signing of informed consent up to 1 year
Progression time after interruption	From signing of informed consent up to 1 year

Trial Locations

Locations (17)

Hospital Comarcal de Barbastro; 🇪🇸 Huesca, Spain

Hospital Arnau de Vilanova; 🇪🇸 Lleida, Spain

Clínica Román; 🇪🇸 Madrid, Spain

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Madrid Norte Sanchinarro; 🇪🇸 Madrid, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Clínica Esperanza de Triana; 🇪🇸 Seville, Spain

Hospital MD Anderson; 🇪🇸 Madrid, Spain

Hospital Universitario Morales Meseguer; 🇪🇸 Murcia, Spain

Hospital Sanitas La Moraleja; 🇪🇸 Madrid, Spain

Hospital Quirón Madrid; 🇪🇸 Madrid, Spain

Hospital Clínico Universitario de Salamanca; 🇪🇸 Salamanca, Spain

Hospital Universitario Virgen del Rocío; 🇪🇸 Seville, Spain

Hospital Virgen Macarena; 🇪🇸 Seville, Spain

Hospital Miguel Servet; 🇪🇸 Zaragoza, Spain

Hospital de Navarra; 🇪🇸 Navarra, Spain

Complejo Hospitalario de Jaen; 🇪🇸 Jaen, Spain