Extended Treatment in Metastatic Breast Cancer With Eribulin (EXTER)

July 21, 2023 updated by: Eisai Limited

Long-term Eribulin Treatment in Metastatic Breast Cancer: A Multicenter, Case-study Analysis

Decision-making for treatment of metastatic breast cancer after the second line of chemotherapy was limited by the lack of established predictive factors of benefit for further chemotherapy regimens. Eribulin has emerged as the only single agent demonstrating an overall survival improvement in the third-line setting or beyond. The purpose of this study was to define the clinical profile of metastatic breast cancer participants achieving long-term benefit from chemotherapy with eribulin in the third-line setting or beyond.

Study Overview

Status

Completed

Conditions

Detailed Description

This was a multicenter, retrospective, observational, case study analysis to assess long-term eribulin treatment in metastatic breast cancer. The study was conducted in 26 Spanish hospitals participating in a national pre-market access program to eribulin between 2011 and 2014. An exploratory comparison with a group of short-term responders included in a similar observational study was performed.

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Badajoz, Spain
      • Cáceres, Spain
      • Jaen, Spain
      • Lleida, Spain
      • Madrid, Spain
      • Murcia, Spain
      • Málaga, Spain
      • Ourense, Spain
      • Salamanca, Spain
      • Sevilla, Spain
      • Valencia, Spain
      • Zaragoza, Spain
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain
    • Gran Canaria
      • Las Palmas De Gran Canarias, Gran Canaria, Spain
    • Guipuzcoa
      • San Sebastián, Guipuzcoa, Spain
    • Huesca
      • Barbastro, Huesca, Spain
    • Madrid
      • Alcorcón, Madrid, Spain
      • Aravaca, Madrid, Spain
      • Pozuelo de Alarcón, Madrid, Spain
    • Navarra
      • Pamplona, Navarra, Spain
    • Vizcaya
      • Bilbao, Vizcaya, Spain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants with Advanced or Metastatic Breast Cancer on Eribulin for at least 7 months

Description

Inclusion criteria:

  • Participants with Advanced or Metastatic Breast Cancer on Eribulin for at least 7 months

Exclusion criteria:

  • Lack of accessible clinical records

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Participants treated with eribulin for at least 7 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: up to 7 months
up to 7 months
Progression free survival (PFS)
Time Frame: up to 7 months
up to 7 months
Objective response rate
Time Frame: up to 7 months
up to 7 months
Time to response
Time Frame: up to 7 months
up to 7 months
Post progression survival
Time Frame: up to 7 months
up to 7 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events/serious adverse events/toxic deaths as a measure of safety
Time Frame: up to 7 months
up to 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

May 10, 2016

First Submitted That Met QC Criteria

May 10, 2016

First Posted (Estimated)

May 11, 2016

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 21, 2023

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBU-SW-H-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe