Eribulin Use for the Treatment of Advanced Breast Cancer: A Prospective Observational Registry

April 14, 2016 updated by: Eisai Limited

Eribulin (HALAVEN) Use for the Treatment of Advanced Breast Cancer: A Prospective Observational Registry

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

77

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark
      • Copenhagen, Denmark
  • Ireland
      • Dublin, Ireland
  • United Kingdom
      • Bath, United Kingdom
      • Cottingham, United Kingdom
      • Derby, United Kingdom
      • London, United Kingdom
      • Maidstone, United Kingdom
      • Manchester, United Kingdom
      • Norwich, United Kingdom
      • Oxford, United Kingdom
      • Plymouth, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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.

Description

Inclusion Criteria

The participants have to meet all of the following criteria to be eligible to enter into the prospective registry:

  1. Participants older than 18 years of age
  2. Willing and able to provide informed consent
  3. Diagnosis of locally advanced or metastatic breast cancer
  4. 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
  5. Adequate bone marrow, liver, and renal function
  6. Life expectancy greater than 12 weeks

Exclusion Criteria

Participants meeting the following criteria will not be permitted to enter the study:

  1. Prior treatment with eribulin
  2. Participants who have received more than two prior chemotherapeutic regimens for advanced disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time Frame: From date of first administration of study drug up to 30 days after last administration of study drug or until approximately 2 years
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 Outcome Measures

Outcome Measure
Time Frame
Tumour response
Time Frame: From date of enrollment, Day 1 and Day 8 of every 21 day cycle or up to approximately 2 years
From date of enrollment, Day 1 and Day 8 of every 21 day cycle or up to approximately 2 years
Overall survival (OS)
Time Frame: From date of first administration of study drug to date of death or up to approximately 2 years
From date of first administration of study drug to date of death or up to approximately 2 years
Demographic and clinical characteristics
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Duration of treatment
Time Frame: Historical data collected at Baseline
Historical data collected at Baseline
Incidence of dose delays
Time Frame: From date of first administration up to approximately 2 years
From date of first administration up to approximately 2 years
Incidence of dose reductions
Time Frame: From date of first administration up to approximately 2 years
From date of first administration up to approximately 2 years
Relative dose intensity (RDI) of eribulin
Time Frame: From date of first administration up to approximately 2 years
From date of first administration up to approximately 2 years
Treatment patterns for locally advanced or metastatic breast cancer
Time Frame: Historical data collected at Baseline
Historical data collected at Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Limited

Investigators

  • Study Director: Hartmut Kristeleit, Guy's Hospital, Great Maze Pond

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

May 11, 2015

First Submitted That Met QC Criteria

May 11, 2015

First Posted (Estimate)

May 13, 2015

Study Record Updates

Last Update Posted (Estimate)

April 15, 2016

Last Update Submitted That Met QC Criteria

April 14, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBU-N-H-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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