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

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ClinicalTrials.gov Identifier: NCT02443428
Recruitment Status : Completed
First Posted : May 13, 2015
Last Update Posted : April 15, 2016
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Limited )

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.

Condition or disease
Breast Cancer

Study Type : Observational
Actual Enrollment : 77 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Eribulin (HALAVEN) Use for the Treatment of Advanced Breast Cancer: A Prospective Observational Registry
Study Start Date : August 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.



Primary Outcome Measures :
  1. 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.


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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443428


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
Sponsors and Collaborators
Eisai Limited
Investigators
Study Director: Hartmut Kristeleit Guy's Hospital, Great Maze Pond

Responsible Party: Eisai Limited
ClinicalTrials.gov Identifier: NCT02443428     History of Changes
Other Study ID Numbers: OBU-N-H-01
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: April 2016

Keywords provided by Eisai Inc. ( Eisai Limited ):
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases