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

NCT ID: NCT02790320

Last Updated: 2016-06-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 112 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2012-11-30

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.

Conditions

Metastatic Breast Cancer

Study Design

• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Farmacêutica S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Comarcal de Barbastro

Huesca, , Spain

Complejo Hospitalario de Jaen

Jaén, , 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, , Spain

Countries

Spain

Other Identifiers

OBU-SW-H-01

Identifier Type: -

Identifier Source: org_study_id