Eribulin [Halaven] Use For the Treatment of Advanced Breast Cancer (EUFORIA-1)

Eribulin [Halaven] Use For the Treatment of Advanced Breast Cancer: Observational Retrospective Analysis

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.

Study Overview

• Status: Completed
• Conditions: Metastatic 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 Type: Observational
• Enrollment (Actual): 112

Contacts and Locations

Study Locations

• Spain
  • Huesca, Spain
    • Hospital Comarcal de Barbastro
  • Jaen, Spain
    • Complejo Hospitalario de Jaén
  • Lleida, Spain
    • Hospital Arnau de Vilanova
  • Madrid, Spain
    • Hospital 12 de Octubre
  • Madrid, Spain
    • Hospital Clinico San Carlos
  • Madrid, Spain
    • Hospital MD Anderson
  • Madrid, Spain
    • Hospital Quiron Madrid
  • Madrid, Spain
    • Hospital Madrid Norte Sanchinarro
  • Madrid, Spain
    • Clínica Román
  • Madrid, Spain
    • Hospital Sanitas La Moraleja
  • Murcia, Spain
    • Hospital Universitario Morales Meseguer
  • Navarra, Spain
    • Hospital de Navarra
  • Salamanca, Spain
    • Hospital Clinico Universitario de Salamanca
  • Seville, Spain
    • Hospital Universitario Virgen del Rocío
  • Seville, Spain
    • Clínica Esperanza de Triana
  • Seville, Spain
    • Hospital Virgen Macarena
  • Zaragoza, Spain
    • Hospital Miguel Servet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with locally recurrent or metastatic advanced breast cancer who were treated with eribulin

Description

Inclusion criteria:

1. Patients diagnosed with locally recurrent or metastatic advanced breast cancer, previously treated with taxanes and anthracyclines, unless these were not indicated.
2. Clinical and/or radiological documentation of location and extension of the disease at the time of starting treatment with eribulin. Patients with measurable diseases and those patients who only have non-measurable lesions are eligible.
3. Medical history documentation including analytical control data (blood count and serum chemistry including hepatic and renal functions) carried out at least one week before starting treatment with eribulin. (Determining the CA15-3 tumor marker is not indispensable).
4. Eribulin monotherapy (at least 1 dose) between April 2011 and March 2012, both inclusive.
5. Availability of a medical history allowing monitoring of clinical progression of the patients during and after treatment with eribulin.

Exclusion criteria:

1. Diagnosis of any type of cancer in the last 5 years, except for non-melanoma skin cancer, cervical intraepithelial neoplasia or contralateral breast cancer.
2. Patients having received any other anti-tumor treatment, whether conventional or experimental, during the week prior to starting treatment with eribulin. Treatment with bisphosphonate and corticoids is allowed if they are clinically indicated and started 28 days before treatment with eribulin.

3. Lack of clinical status documentation after completing treatment with eribulin or, at least, after having been administered 3 initial cycles. This can arise in any of the following cases (they are not excluding):

   1. Patients whose Medical History does not state the reason and date for interruption of treatment with eribulin and their subsequent clinical progression.
   2. Patients still undergoing treatment with eribulin on March 31, 2012, for whom there is no data for at least the first 3 cycles.

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with locally recurrent or metastatic breast cancer; Patients received 1.4 mg/m2 eribulin, administered intravenously on day 1 and 8 of each 21 day cycle until disease progression or unmanageable toxicity, per routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical benefit rate	From signing of informed consent up to 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective response rate	From signing of informed consent up to 1 year
Overall 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
Duration of response	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 time after interruption	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

Collaborators and Investigators

• Sponsor: Eisai Farmacêutica S.A.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: May 31, 2016
• First Submitted That Met QC Criteria: June 2, 2016
• First Posted (Estimate): June 3, 2016

Study Record Updates

• Last Update Posted (Estimate): June 3, 2016
• Last Update Submitted That Met QC Criteria: June 2, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Breast cancer; Halaven; Eribulin mesylate
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: OBU-SW-H-01