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

March 15, 2016 updated by: ARCAGY/ GINECO GROUP

A PHASE II TRIAL EVALUATING THE COMBINATION OF ERIBULIN (HALAVEN®) + BEVACIZUMAB (AVASTIN®) AS A FIRST LINE TREATMENT IN PATIENTS WITH METASTATIC HER2- BREAST CANCER

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Drug: Bevacizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicity based on the CTCAE v4.03 criteria
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ARCAGY/ GINECO GROUP

Investigators

  • Principal Investigator: Anne-Claire HARDY-BESSARD, MD, Clinique Armoricaine de Radiologie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

September 10, 2013

First Submitted That Met QC Criteria

September 10, 2013

First Posted (Estimate)

September 13, 2013

Study Record Updates

Last Update Posted (Estimate)

March 17, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GINECO-BR110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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