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OpenTrials
Completed

NCT Number: NCT02769364

Extended Treatment in Metastatic Breast Cancer With Eribulin

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Santiago de Compostela, A Coruña, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Lack of accessible clinical records

Treatment and study plan

Primary outcomes

  1. Overall survival

    Time frame: up to 7 months

  2. Progression free survival (PFS)

    Time frame: up to 7 months

  3. Objective response rate

    Time frame: up to 7 months

  4. Time to response

    Time frame: up to 7 months

  5. Post progression survival

    Time frame: up to 7 months

Secondary outcomes

  1. Number of participants with adverse events/serious adverse events/toxic deaths as a measure of safety

    Time frame: up to 7 months

Sponsors and collaborators

Lead sponsor

Eisai Limited

Industry

Registry information

Official study title

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

Acronym: EXTER

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 11, 2016
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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