First Line Metastatic Breast Cancer Treatment (ESMERALDA)

NCT ID: NCT01941407

Last Updated: 2016-03-17

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

Clinical Phase

PHASE2

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-03-31

Brief Summary

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The efficacy of eribulin is now well known in metastatic breast cancer. Furthermore, a phase III combine study ( chemo + bev)in metastatic first line shown a gain in PFS with no extra toxicities.

It could be interesting to explore the combination of bev + eribulin in first line metastatic breast cancer.

Detailed Description

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Conditions

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Metastatic Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Association eribulin and bevacizumab

Drug: eribulin 1,23mg/m²; d1 and d8 in IV, all 3 weeks until 6 cycles or progression Drug: bevacizumab 15m/kg ; d1 in IV, all 3 weeks until 6 cycles or progression or toxicity

Group Type EXPERIMENTAL

Eribulin

Intervention Type DRUG

Eribulin: 1,23mg/m² d1, d8, IV Bevacizumab: 15mg/kg d1, IV

Interventions

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Eribulin

Eribulin: 1,23mg/m² d1, d8, IV Bevacizumab: 15mg/kg d1, IV

Intervention Type DRUG

Other Intervention Names

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Drug: Bevacizumab

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 ans
* Patient with metastatic mammary adenocarcinoma
* Hormone receptors ER and PR positive or negative for HER 2 negative

Exclusion Criteria

* Prior chemotherapy for metastatic disease
* Previous treatment with eribulin or bevacizumab
* Presence of symptomatic brain metastases or meningeal
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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ARCAGY/ GINECO GROUP

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne-Claire HARDY-BESSARD, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Armoricaine de Radiologie

Locations

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Centre Paul Papin

Angers, , France

Site Status

Centre Hospitalier d'Auxerre

Auxerre, , France

Site Status

Institut Ste Catherine

Avignon, , France

Site Status

Clinique Tivoli

Bordeaux, , France

Site Status

Hôpital Fleyriat

Bourg-en-Bresse, , France

Site Status

Hôpital Morvan - Centre Hospitalier Universitaire

Brest, , France

Site Status

centre Francois baclesse

Caen, , France

Site Status

Hôpital Privé Sainte-Marie

Chalon-sur-Saône, , France

Site Status

Centre Hospitalier William Morey

Chalon-sur-Saône, , France

Site Status

Centre d'Oncologie et de Radiothérapie

Dijon, , France

Site Status

Centre Hospitalier la Dracénie

Draguignan, , France

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Centre Hospitalier Intercommunal

Fréjus, , France

Site Status

Hôpital Privé Drôme Ardèche - Clinique Pasteur

Guilherand-Granges, , France

Site Status

Clinique de la Sauvegarde

Lyon, , France

Site Status

Centre Léon Bérard

Lyon, , France

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Hôpital Privé Clairval

Marseille, , France

Site Status

Hôpital de Mont-de-Marsan

Mont-de-Marsan, , France

Site Status

Centre d'oncologie de Gentilly

Nancy, , France

Site Status

Centre Catherine de Sienne

Nantes, , France

Site Status

Centre Antoine Lacassagne

Nice, , France

Site Status

Centre Hospitalier Régional

Orléans, , France

Site Status

Institut Curie - Hopital Claudius Régaud

Paris, , France

Site Status

Hôpital Cochin

Paris, , France

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Groupe Hospitalier Saint-Joseph

Paris, , France

Site Status

Centre Catalan d'Oncologie

Perpignan, , France

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Centre Hospitalier Lyon-sud

Pierre-Bénite, , France

Site Status

Centre Hospitalier de la Région d'Annecy

Pringy, , France

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Clinique Courlancy

Reims, , France

Site Status

Institut Jean Godinot

Reims, , France

Site Status

Centre Henri Becquerel

Rouen, , France

Site Status

Anne-Claire Hardy-Bessard, MD

Saint-Brieuc, , France

Site Status

Clinique Armoricaine de Radiologie

Saint-Brieuc, , France

Site Status

Centre Hospitalier Privé de Saint-Grégoire

Saint-Grégoire, , France

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GHPSO - Site Senlis

Senlis, , France

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Centre de Radiothérapie - Clinique Sainte-Anne

Strasbourg, , France

Site Status

Centre Hospitalier de Thonon-les-Bains

Thonon-les-Bains, , France

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Clinique Pasteur

Toulouse, , France

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CHU Bretonneau

Tours, , France

Site Status

Centre Hospitalier de Valence

Valence, , France

Site Status

Centre Hospitalier Bretagne Atlantique

Vannes, , France

Site Status

Countries

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France

Other Identifiers

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GINECO-BR110

Identifier Type: -

Identifier Source: org_study_id

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