ClinicalTrials.gg
CompletedNCT02769364EXTERUpdated Jul 24, 2023

Extended Treatment in Metastatic Breast Cancer With Eribulin

An observational study in Breast Cancer, sponsored by Eisai Limited. Completed at 21 sites in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-24.

Sponsored by Eisai Limited · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
45
Ages
18 Years and older
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Breast Cancer

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Keywords

  • Advanced or Metastatic Breast Cancer
  • Eribulin
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In context

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

This study's enrollment of 45 is below the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.

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Lead sponsor

Eisai Limited is the lead sponsor of 48 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion criteria:

  • Lack of accessible clinical records
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
45 participants (actual)

Groups and cohorts

  • Participants treated with eribulin for at least 7 months
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What researchers measure

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

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Study locations

21 sites
  • Santiago de Compostela, A Coruña, Spain
  • Las Palmas De Gran Canarias, Gran Canaria, Spain
  • San Sebastián, Guipuzcoa, Spain
  • Barbastro, Huesca, Spain
  • Alcorcón, Madrid, Spain
  • Aravaca, Madrid, Spain
  • Pozuelo de Alarcón, Madrid, Spain
  • Pamplona, Navarra, Spain
  • Bilbao, Vizcaya, 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
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02769364
Lead sponsor
Eisai Limited
Responsible party
Sponsor
First posted
May 11, 2016
Start date
Nov 2013
Primary completion
Jun 2014
Completion
Jun 2014
Last update
Jul 24, 2023
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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