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

Primary Purpose

Metastatic Breast Cancer

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Eribulin
Sponsored by
ARCAGY/ GINECO GROUP
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Paul Papin
  • Centre Hospitalier d'Auxerre
  • Institut Ste Catherine
  • Clinique Tivoli
  • Hôpital Fleyriat
  • Hôpital Morvan - Centre Hospitalier Universitaire
  • centre Francois baclesse
  • Hôpital Privé Sainte-Marie
  • Centre Hospitalier William Morey
  • Centre d'Oncologie et de Radiothérapie
  • Centre Hospitalier la Dracénie
  • Centre Hospitalier Intercommunal
  • Hôpital Privé Drôme Ardèche - Clinique Pasteur
  • Clinique de la Sauvegarde
  • Centre Léon Bérard
  • Hôpital Privé Clairval
  • Hôpital de Mont-de-Marsan
  • Centre d'oncologie de Gentilly
  • Centre Catherine de Sienne
  • Centre Antoine Lacassagne
  • Centre Hospitalier Régional
  • Institut Curie - Hopital Claudius Régaud
  • Hôpital Cochin
  • Groupe Hospitalier Saint-Joseph
  • Centre Catalan d'Oncologie
  • Centre Hospitalier Lyon-sud
  • Centre Hospitalier de la Région d'Annecy
  • Clinique Courlancy
  • Institut Jean Godinot
  • Centre Henri Becquerel
  • Clinique Armoricaine de Radiologie
  • Anne-Claire Hardy-Bessard, MD
  • Centre Hospitalier Privé de Saint-Grégoire
  • GHPSO - Site Senlis
  • Centre de Radiothérapie - Clinique Sainte-Anne
  • Centre Hospitalier de Thonon-les-Bains
  • Clinique Pasteur
  • CHU Bretonneau
  • Centre Hospitalier de Valence
  • Centre Hospitalier Bretagne Atlantique

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Association eribulin and bevacizumab

Arm Description

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

Outcomes

Primary Outcome Measures

Number of patient with non progressive disease
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

Toxicity based on the CTCAE v4.03 criteria

Full Information

First Posted
September 10, 2013
Last Updated
March 15, 2016
Sponsor
ARCAGY/ GINECO GROUP
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1. Study Identification

Unique Protocol Identification Number
NCT01941407
Brief Title
First Line Metastatic Breast Cancer Treatment (ESMERALDA)
Acronym
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ARCAGY/ GINECO GROUP

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Association eribulin and bevacizumab
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Eribulin
Other Intervention Name(s)
Drug: Bevacizumab
Intervention Description
Eribulin: 1,23mg/m² d1, d8, IV Bevacizumab: 15mg/kg d1, IV
Primary Outcome Measure Information:
Title
Number of patient with non progressive disease
Description
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%.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Toxicity based on the CTCAE v4.03 criteria
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Claire HARDY-BESSARD, MD
Organizational Affiliation
Clinique Armoricaine de Radiologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Paul Papin
City
Angers
Country
France
Facility Name
Centre Hospitalier d'Auxerre
City
Auxerre
ZIP/Postal Code
89000
Country
France
Facility Name
Institut Ste Catherine
City
Avignon
Country
France
Facility Name
Clinique Tivoli
City
Bordeaux
Country
France
Facility Name
Hôpital Fleyriat
City
Bourg-en-Bresse
ZIP/Postal Code
01012
Country
France
Facility Name
Hôpital Morvan - Centre Hospitalier Universitaire
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
centre Francois baclesse
City
Caen
Country
France
Facility Name
Hôpital Privé Sainte-Marie
City
Chalon sur Saône
ZIP/Postal Code
71100
Country
France
Facility Name
Centre Hospitalier William Morey
City
Chalon sur Saône
Country
France
Facility Name
Centre d'Oncologie et de Radiothérapie
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Centre Hospitalier la Dracénie
City
Draguignan
ZIP/Postal Code
83300
Country
France
Facility Name
Centre Hospitalier Intercommunal
City
Fréjus
Country
France
Facility Name
Hôpital Privé Drôme Ardèche - Clinique Pasteur
City
Guilherand-Granges
ZIP/Postal Code
07500
Country
France
Facility Name
Clinique de la Sauvegarde
City
Lyon
ZIP/Postal Code
69337
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Hôpital Privé Clairval
City
Marseille
Country
France
Facility Name
Hôpital de Mont-de-Marsan
City
Mont-de-Marsan
ZIP/Postal Code
40024
Country
France
Facility Name
Centre d'oncologie de Gentilly
City
Nancy
Country
France
Facility Name
Centre Catherine de Sienne
City
Nantes
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
Country
France
Facility Name
Centre Hospitalier Régional
City
Orléans
Country
France
Facility Name
Institut Curie - Hopital Claudius Régaud
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Hôpital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Groupe Hospitalier Saint-Joseph
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
Centre Catalan d'Oncologie
City
Perpignan
ZIP/Postal Code
66000
Country
France
Facility Name
Centre Hospitalier Lyon-sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
Centre Hospitalier de la Région d'Annecy
City
Pringy
ZIP/Postal Code
74374
Country
France
Facility Name
Clinique Courlancy
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
Institut Jean Godinot
City
Reims
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
Country
France
Facility Name
Clinique Armoricaine de Radiologie
City
Saint Brieuc
Country
France
Facility Name
Anne-Claire Hardy-Bessard, MD
City
Saint-Brieuc
ZIP/Postal Code
22015
Country
France
Facility Name
Centre Hospitalier Privé de Saint-Grégoire
City
Saint-Grégoire
ZIP/Postal Code
35760
Country
France
Facility Name
GHPSO - Site Senlis
City
Senlis
ZIP/Postal Code
60309
Country
France
Facility Name
Centre de Radiothérapie - Clinique Sainte-Anne
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Centre Hospitalier de Thonon-les-Bains
City
Thonon-Les-Bains
ZIP/Postal Code
74203
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31076
Country
France
Facility Name
CHU Bretonneau
City
Tours
Country
France
Facility Name
Centre Hospitalier de Valence
City
Valence
ZIP/Postal Code
26953
Country
France
Facility Name
Centre Hospitalier Bretagne Atlantique
City
Vannes
Country
France

12. IPD Sharing Statement

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First Line Metastatic Breast Cancer Treatment (ESMERALDA)

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