Retroprospective Real Life Observatory of Eribulin

Study Overview
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Brief Summary
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The objective of this observatory is to evaluate the effecacy of Eribulin in patients with metastatic breast cancer on a recent prescription period. Part of the data collection will be retrospective and the other part will be prospective for patients started treatment by Eribulin between November 2014 and September 2015. It will allow a better assessment on the safety profile of this drug.

Detailed Description
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Approximately one third of patients treated for localized breast cancer will present a metastatic evolution and 5% of patients are metastatic immediately. At this stage, the malignancy is incurable with a median survival from 2 to 3 years. Metastatic breast cancer treatment is part of a multidisciplinary approach. These two objectives are to prolong survival and improve quality of life. At present, there is no standard after the first line of chemotherapy, with fe strategy studies Eribulin is now a new therapeutic option to consider. Many patients have benefited from this treatment option and it seems interesting to evaluate in real life the effecacy and tolerance of chemotherapy.

Official Title
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Activity and Toxicity Profile of Eribulin Mesylate in Pretreated Metastatic Breast Cancer: an Observational Multicentric Retroprospective Study

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Other: Eribulin (ReProLine)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Patient with breast cancer, histologically proven, metastatic or locally advanced Patient treated by Eribulin between January and October 2014 (for the retrospective part) or between November 2014 and September 2015 (for the prospective part). Patient with at least an assessment of the response to Eribulin Exclusion Criteria: Presence of other neoplasia Man

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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 |
| --- | --- |
| Reproline<br>this is an observational trial ; there is no intervention | Other: Eribulin (ReProLine)<br>* this is an observational trial ; there is no intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Overall survival is defined as the time between the first administration of Eribulin and death from any cause. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival by subgroup | Overall survival is defined as the time between the first administration of Eribulin and death from any cause in the following subgroups: According to the administration line of Eribulin: administration in third line or more versus administration in first or second line or for locally advanced cancer, in HER2 + population in triple negative population in the elderly (> 70 years) in the overweight population (BMI> 30) | 1 year | 
| Progression free survival | Progression-free survival is defined as the time between the first administration of Eribulin and the first demonstrated progression by image | 1 year | 
| Treatment response rate | Treatment response rate will be assessed by: the best response obtained between the first administration of treatment with Eribulin and demonstrated progression by image (according to RECIST 1.1 criteria) or clinical the clinical benefit (number of complete responses, partial responses or persistent stabilities mare than 6 months). | 1 year | 
| Treatment's tolerance | The treatment's tolerance will be assessed by collecting adverse events ≥ grade 3 quoted according to NCI CTCAE v4.0 classification. | 1 year |