NCT02443428

Brief Summary

The purpose of this prospective observational registry is to monitor safety of eribulin in routine clinical practice. Additionally, this study will also assess the effectiveness of eribulin in real-life settings.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2013

Typical duration for all trials

Geographic Reach
3 countries

12 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

August 1, 2013

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 13, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

April 15, 2016

Status Verified

April 1, 2016

Enrollment Period

2.2 years

First QC Date

May 11, 2015

Last Update Submit

April 14, 2016

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events (AEs) and serious adverse events (SAEs)

    Safety assessment will consist of monitoring of all AEs, including SAEs at every visit. All participants will be evaluable for safety from the time of their first treatment with eribulin.

    From date of first administration of study drug up to 30 days after last administration of study drug or until approximately 2 years

Secondary Outcomes (8)

  • Tumour response

    From date of enrollment, Day 1 and Day 8 of every 21 day cycle or up to approximately 2 years

  • Overall survival (OS)

    From date of first administration of study drug to date of death or up to approximately 2 years

  • Demographic and clinical characteristics

    Up to approximately 2 years

  • Duration of treatment

    Historical data collected at Baseline

  • Incidence of dose delays

    From date of first administration up to approximately 2 years

  • +3 more secondary outcomes

Study Arms (1)

Eribulin Mesilate

Participants will be treated in accordance with normal clinical practice. The recommend dose of eribulin is 1.23 mg/m2 administered intravenously on days 1 and 8 of every 21-day cycle. Treatment with eribulin is continued until disease progression, onset of unacceptable drug toxicities, or participant/physician's request to discontinue.

Eligibility Criteria

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

Participants with locally advanced or metastatic breast cancer who have progressed after up to two chemotherapeutic regimens for advanced disease will be prospectively included in the registry. Prior therapy should have included an anthracycline and a taxanes unless the patient was not suitable for these treatments.

You may qualify if:

  • The participants have to meet all of the following criteria to be eligible to enter into the prospective registry:
  • Participants older than 18 years of age
  • Willing and able to provide informed consent
  • Diagnosis of locally advanced or metastatic breast cancer
  • Progression after up to two previous chemotherapy regimens for advanced disease. Prior therapy should have included an anthracycline and a taxanes in either the adjuvant or advanced setting unless not suitable
  • Adequate bone marrow, liver, and renal function
  • Life expectancy greater than 12 weeks

You may not qualify if:

  • Participants meeting the following criteria will not be permitted to enter the study:
  • Prior treatment with eribulin
  • Participants who have received more than two prior chemotherapeutic regimens for advanced disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Aarhus, Denmark

Location

Unknown Facility

Copenhagen, Denmark

Location

Unknown Facility

Dublin, Ireland

Location

Unknown Facility

Bath, United Kingdom

Location

Unknown Facility

Cottingham, United Kingdom

Location

Unknown Facility

Derby, United Kingdom

Location

Unknown Facility

London, United Kingdom

Location

Unknown Facility

Maidstone, United Kingdom

Location

Unknown Facility

Manchester, United Kingdom

Location

Unknown Facility

Norwich, United Kingdom

Location

Unknown Facility

Oxford, United Kingdom

Location

Unknown Facility

Plymouth, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Hartmut Kristeleit

    Guy's Hospital, Great Maze Pond

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2015

First Posted

May 13, 2015

Study Start

August 1, 2013

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

April 15, 2016

Record last verified: 2016-04

Locations

IE(1)DK(2)GB(9)