Clinical trial NCT01941407: First Line Metastatic Breast Cancer Treatment (ESMERALDA)
Official title: A PHASE II TRIAL EVALUATING THE COMBINATION OF ERIBULIN (HALAVEN®) + BEVACIZUMAB (AVASTIN®) AS A FIRST LINE TREATMENT IN PATIENTS WITH METASTATIC HER2- BREAST CANCER
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Lead sponsor: ARCAGY/ GINECO GROUP
Sponsor class: OTHER
First posted: 2013-09-13
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of patient with non progressive disease
timeFrame: 12 months
Secondary outcomes:
measure: Toxicity based on the CTCAE v4.03 criteria
timeFrame: 12 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Paul Papin
city: Auxerre
country: France
facility: Centre Hospitalier d'Auxerre
city: Avignon
country: France
facility: Institut Ste Catherine
city: Bordeaux
country: France
facility: Clinique Tivoli
city: Bourg-en-Bresse
country: France
facility: Hôpital Fleyriat
city: Brest
country: France
facility: Hôpital Morvan - Centre Hospitalier Universitaire
city: Caen
country: France
facility: centre Francois baclesse
city: Chalon sur Saône
country: France
facility: Hôpital Privé Sainte-Marie
city: Chalon sur Saône
country: France
facility: Centre Hospitalier William Morey
city: Dijon
country: France
facility: Centre d'Oncologie et de Radiothérapie
city: Draguignan
country: France
facility: Centre Hospitalier la Dracénie
city: Fréjus
country: France
facility: Centre Hospitalier Intercommunal
city: Guilherand-Granges
country: France
facility: Hôpital Privé Drôme Ardèche - Clinique Pasteur
city: Lyon
country: France
facility: Clinique de la Sauvegarde
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Hôpital Privé Clairval
city: Mont-de-Marsan
country: France
facility: Hôpital de Mont-de-Marsan
city: Nancy
country: France
facility: Centre d'oncologie de Gentilly
city: Nantes
country: France
facility: Centre Catherine de Sienne
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Orléans
country: France
facility: Centre Hospitalier Régional
city: Paris
country: France
facility: Institut Curie - Hopital Claudius Régaud
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Groupe Hospitalier Saint-Joseph
city: Perpignan
country: France
facility: Centre Catalan d'Oncologie
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon-sud
city: Pringy
country: France
facility: Centre Hospitalier de la Région d'Annecy
city: Reims
country: France
facility: Clinique Courlancy
city: Reims
country: France
facility: Institut Jean Godinot
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint Brieuc
country: France
facility: Clinique Armoricaine de Radiologie
city: Saint-Brieuc
country: France
facility: Anne-Claire Hardy-Bessard, MD
city: Saint-Grégoire
country: France
facility: Centre Hospitalier Privé de Saint-Grégoire
city: Senlis
country: France
facility: GHPSO - Site Senlis
city: Strasbourg
country: France
facility: Centre de Radiothérapie - Clinique Sainte-Anne
city: Thonon-Les-Bains
country: France
facility: Centre Hospitalier de Thonon-les-Bains
city: Toulouse
country: France
facility: Clinique Pasteur
city: Tours
country: France
facility: CHU Bretonneau
city: Valence
country: France
facility: Centre Hospitalier de Valence
city: Vannes
country: France
facility: Centre Hospitalier Bretagne Atlantique
Study officials:
affiliation: Clinique Armoricaine de Radiologie
name: Anne-Claire HARDY-BESSARD, MD
role: PRINCIPAL_INVESTIGATOR
References: