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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No