NCT02769364

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2013

Shorter than P25 for all trials

Geographic Reach
1 country

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
Last Updated

July 24, 2023

Status Verified

May 1, 2016

Enrollment Period

7 months

First QC Date

May 10, 2016

Last Update Submit

July 21, 2023

Conditions

Keywords

Advanced or Metastatic Breast CancerEribulin

Outcome Measures

Primary Outcomes (5)

  • Overall survival

    up to 7 months

  • Progression free survival (PFS)

    up to 7 months

  • Objective response rate

    up to 7 months

  • Time to response

    up to 7 months

  • Post progression survival

    up to 7 months

Secondary Outcomes (1)

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

    up to 7 months

Study Arms (1)

Participants treated with eribulin for at least 7 months

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Lack of accessible clinical records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Unknown Facility

Santiago de Compostela, A Coruña, Spain

Location

Unknown Facility

Las Palmas de Gran Canarias, Gran Canaria, Spain

Location

Unknown Facility

San Sebastián, Guipuzcoa, Spain

Location

Unknown Facility

Barbastro, Huesca, Spain

Location

Unknown Facility

Alcorcón, Madrid, Spain

Location

Unknown Facility

Aravaca, Madrid, Spain

Location

Unknown Facility

Pozuelo de Alarcón, Madrid, Spain

Location

Unknown Facility

Pamplona, Navarre, Spain

Location

Unknown Facility

Bilbao, Vizcaya, Spain

Location

Unknown Facility

Badajoz, Spain

Location

Unknown Facility

Cáceres, Spain

Location

Unknown Facility

Jaén, Spain

Location

Unknown Facility

Lleida, Spain

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

Málaga, Spain

Location

Unknown Facility

Murcia, Spain

Location

Unknown Facility

Ourense, Spain

Location

Unknown Facility

Salamanca, Spain

Location

Unknown Facility

Seville, Spain

Location

Unknown Facility

Valencia, Spain

Location

Unknown Facility

Zaragoza, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2016

First Posted

May 11, 2016

Study Start

November 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

July 24, 2023

Record last verified: 2016-05

Locations