Extended Treatment in Metastatic Breast Cancer With Eribulin

Breast Cancer Clinical Trial

— EXTER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02769364
• Other study ID #: OBU-SW-H-05
• Status: Completed
• Start date: November 2013
• Est. completion date: June 2014

Study information

• Verified date: May 2016
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

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

Exclusion criteria:

• Lack of accessible clinical records

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Limited

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		up to 7 months
Primary	Progression free survival (PFS)		up to 7 months
Primary	Objective response rate		up to 7 months
Primary	Time to response		up to 7 months
Primary	Post progression survival		up to 7 months
Secondary	Number of participants with adverse events/serious adverse events/toxic deaths as a measure of safety		up to 7 months