Retroprospective Real Life Observatory of Eribulin

NCT ID: NCT02393287

Last Updated: 2019-05-09

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

753 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-01-31

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.

Conditions

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Metastatic Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Reproline

this is an observational trial ; there is no intervention

Eribulin (ReProLine)

Intervention Type OTHER

this is an observational trial ; there is no intervention

Interventions

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Eribulin (ReProLine)

this is an observational trial ; there is no intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 18 years
2. Patient with breast cancer, histologically proven, metastatic or locally advanced
3. Patient treated by Eribulin between January and October 2014 (for the retrospective part) or between November 2014 and September 2015 (for the prospective part).
4. Patient with at least an assessment of the response to Eribulin

Exclusion Criteria

1. Presence of other neoplasia
2. Man
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Institut Cancerologie de l'Ouest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne PATSOURIS, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancerologie de l'Ouest

Locations

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Institut de Cancerologie de l'Ouest

Angers, , France

Site Status

CHU Jean Minjoz

Besançon, , France

Site Status

CHU

Brest, , France

Site Status

Centre Jean Bernard

Le Mans, , France

Site Status

Centre Léon Berard

Lyon, , France

Site Status

Institut de Cancerologie de l'Ouest

Nantes, , France

Site Status

Centre Jean Godinot

Reims, , France

Site Status

Centre Eugène Marquis

Rennes, , France

Site Status

Centre Henri Becquerel

Rouen, , France

Site Status

Clinique Armoricaine de Radiologie

Saint-Brieuc, , France

Site Status

CH

St-Malo, , France

Site Status

Centre Paul Strauss

Strasbourg, , France

Site Status

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

Other Identifiers

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ICO-A-RSD-2014-07

Identifier Type: -

Identifier Source: org_study_id

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