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First Line Metastatic Breast Cancer Treatment (ESMERALDA) (ESMERALDA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01941407
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : March 17, 2016
Sponsor:
Information provided by (Responsible Party):
ARCAGY/ GINECO GROUP

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.


Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Eribulin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 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
Drug: Eribulin
Eribulin: 1,23mg/m² d1, d8, IV Bevacizumab: 15mg/kg d1, IV
Other Name: Drug: Bevacizumab




Primary Outcome Measures :
  1. Number of patient with non progressive disease [ Time Frame: 12 months ]

    The principal endpoint is to determine the disease control rate (or rate of non-progression) at one year in patients with metastatic breast cancer treated in the first line setting by a combination of eribulin/bevacizumab.

    In this open-label trial, the sample size is calculated based on Simon's two-stage design, used to test whether the disease control rate at one year will be at least 50%, a clinically promising rate, versus a rate of 33%, a rate that is not clinically promising.

    Considering a type I risk (alpha) error of 5%, with 54 patients, this study has an 80% power to detect a disease control rate at one year of 50%.



Secondary Outcome Measures :
  1. Toxicity based on the CTCAE v4.03 criteria [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941407


Locations
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France
Centre Paul Papin
Angers, France
Centre Hospitalier d'Auxerre
Auxerre, France, 89000
Institut Ste Catherine
Avignon, France
Clinique Tivoli
Bordeaux, France
Hôpital Fleyriat
Bourg-en-Bresse, France, 01012
Hôpital Morvan - Centre Hospitalier Universitaire
Brest, France, 29200
centre Francois baclesse
Caen, France
Hôpital Privé Sainte-Marie
Chalon sur Saône, France, 71100
Centre Hospitalier William Morey
Chalon sur Saône, France
Centre d'Oncologie et de Radiothérapie
Dijon, France, 21000
Centre Hospitalier la Dracénie
Draguignan, France, 83300
Centre Hospitalier Intercommunal
Fréjus, France
Hôpital Privé Drôme Ardèche - Clinique Pasteur
Guilherand-Granges, France, 07500
Clinique de la Sauvegarde
Lyon, France, 69337
Centre Léon Bérard
Lyon, France, 69373
Hôpital Privé Clairval
Marseille, France
Hôpital de Mont-de-Marsan
Mont-de-Marsan, France, 40024
Centre d'oncologie de Gentilly
Nancy, France
Centre Catherine de Sienne
Nantes, France
Centre Antoine Lacassagne
Nice, France
Centre Hospitalier Régional
Orléans, France
Institut Curie - Hopital Claudius Régaud
Paris, France, 75005
Hôpital Cochin
Paris, France, 75014
Groupe Hospitalier Saint-Joseph
Paris, France, 75674
Centre Catalan d'Oncologie
Perpignan, France, 66000
Centre Hospitalier Lyon-sud
Pierre-Bénite, France, 69495
Centre Hospitalier de la Région d'Annecy
Pringy, France, 74374
Clinique Courlancy
Reims, France, 51100
Institut Jean Godinot
Reims, France
Centre Henri Becquerel
Rouen, France
Clinique Armoricaine de Radiologie
Saint Brieuc, France
Anne-Claire Hardy-Bessard, MD
Saint-Brieuc, France, 22015
Centre Hospitalier Privé de Saint-Grégoire
Saint-Grégoire, France, 35760
GHPSO - Site Senlis
Senlis, France, 60309
Centre de Radiothérapie - Clinique Sainte-Anne
Strasbourg, France, 67000
Centre Hospitalier de Thonon-les-Bains
Thonon-Les-Bains, France, 74203
Clinique Pasteur
Toulouse, France, 31076
CHU Bretonneau
Tours, France
Centre Hospitalier de Valence
Valence, France, 26953
Centre Hospitalier Bretagne Atlantique
Vannes, France
Sponsors and Collaborators
ARCAGY/ GINECO GROUP
Investigators
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Principal Investigator: Anne-Claire HARDY-BESSARD, MD Clinique Armoricaine de Radiologie

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Responsible Party: ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier: NCT01941407     History of Changes
Other Study ID Numbers: GINECO-BR110
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors