Extended Treatment in Metastatic Breast Cancer With Eribulin

NCT ID: NCT02769364

Last Updated: 2023-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Participants treated with eribulin for at least 7 months

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Lack of accessible clinical records
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Eisai Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Santiago de Compostela, A Coruña, Spain

Site Status

Las Palmas de Gran Canarias, Gran Canaria, Spain

Site Status

San Sebastián, Guipuzcoa, Spain

Site Status

Barbastro, Huesca, Spain

Site Status

Alcorcón, Madrid, Spain

Site Status

Aravaca, Madrid, Spain

Site Status

Pozuelo de Alarcón, Madrid, Spain

Site Status

Pamplona, Navarre, Spain

Site Status

Bilbao, Vizcaya, Spain

Site Status

Badajoz, , Spain

Site Status

Cáceres, , Spain

Site Status

Jaén, , Spain

Site Status

Lleida, , Spain

Site Status

Madrid, , Spain

Site Status

Málaga, , Spain

Site Status

Murcia, , Spain

Site Status

Ourense, , Spain

Site Status

Salamanca, , Spain

Site Status

Seville, , Spain

Site Status

Valencia, , Spain

Site Status

Zaragoza, , Spain

Site Status

Countries

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Spain

Other Identifiers

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OBU-SW-H-05

Identifier Type: -

Identifier Source: org_study_id

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