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

Study Overview
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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.

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

Conditions
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Breast Cancer

Participation Criteria
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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: 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 Exclusion Criteria 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Eribulin Mesilate<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Incidence of dose reductions |  | From date of first administration up to approximately 2 years | 
| Relative dose intensity (RDI) of eribulin |  | From date of first administration up to approximately 2 years | 
| Treatment patterns for locally advanced or metastatic breast cancer |  | Historical data collected at Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer