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

Metastatic Breast Cancer Clinical Trial

— EUFORIA-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02790320
• Other study ID #: OBU-SW-H-01
• Status: Completed
• Phase: N/A
• First received: May 31, 2016
• Last updated: June 2, 2016
• Start date: June 2012
• Est. completion date: November 2012

Study information

• Verified date: April 2016
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: November 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Locations

Country	Name	City	State
Spain	Hospital Comarcal de Barbastro	Huesca
Spain	Complejo Hospitalario de Jaen	Jaen
Spain	Hospital Arnau de Vilanova	Lleida
Spain	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	Hospital Universitario Morales Meseguer	Murcia
Spain	Hospital de Navarra	Navarra
Spain	Hospital Clínico Universitario de Salamanca	Salamanca
Spain	Clínica Esperanza de Triana	Seville
Spain	Hospital Universitario Virgen del Rocío	Seville
Spain	Hospital Virgen Macarena	Seville
Spain	Hospital Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Farmacêutica S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical benefit rate		From signing of informed consent up to 1 year	No
Secondary	Objective response rate		From signing of informed consent up to 1 year	No
Secondary	Overall survival		From signing of informed consent up to 1 year	No
Secondary	Progression-free survival		From signing of informed consent up to 1 year	No
Secondary	Change from baseline in tumor markers CA15-3		Baseline and up to 1 year	No
Secondary	Time to response from start of treatment		From signing of informed consent up to 1 year	No
Secondary	Duration of response		From signing of informed consent up to 1 year	No
Secondary	Duration of stabilization		From signing of informed consent up to 1 year	No
Secondary	Post-treatment survival		From signing of informed consent up to 1 year	No
Secondary	Progression time after interruption		From signing of informed consent up to 1 year	No
Secondary	Number of patients with adverse events / serious adverse events		From signing of informed consent up to 1 year	Yes