First Line Metastatic Breast Cancer Treatment (ESMERALDA)

NCT01941407 | Completed Phase 2 DMC

• 1 other identifier: GINECO-BR110
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 40

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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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%.

  12 months

Secondary Outcomes (1)

• Toxicity based on the CTCAE v4.03 criteria

  12 months

Study Arms (1)

Association eribulin and bevacizumab

EXPERIMENTAL

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

Interventions

Eribulin DRUG

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

Also known as: Drug: Bevacizumab

Association eribulin and bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Prior chemotherapy for metastatic disease
• Previous treatment with eribulin or bevacizumab
• Presence of symptomatic brain metastases or meningeal

Sponsors & Collaborators

• ARCAGY/ GINECO GROUP: lead

Study Sites (40)

Centre Paul Papin

Angers, France

Location

Centre Hospitalier d'Auxerre

Auxerre, 89000, France

Location

Institut Ste Catherine

Avignon, France

Location

Clinique Tivoli

Bordeaux, France

Location

Hôpital Fleyriat

Bourg-en-Bresse, 01012, France

Location

Hôpital Morvan - Centre Hospitalier Universitaire

Brest, 29200, France

Location

centre Francois baclesse

Caen, France

Location

Hôpital Privé Sainte-Marie

Chalon-sur-Saône, 71100, France

Location

Centre Hospitalier William Morey

Chalon-sur-Saône, France

Location

Centre d'Oncologie et de Radiothérapie

Dijon, 21000, France

Location

Centre Hospitalier la Dracénie

Draguignan, 83300, France

Location

Centre Hospitalier Intercommunal

Fréjus, France

Location

Hôpital Privé Drôme Ardèche - Clinique Pasteur

Guilherand-Granges, 07500, France

Location

Clinique de la Sauvegarde

Lyon, 69337, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

Hôpital Privé Clairval

Marseille, France

Location

Hôpital de Mont-de-Marsan

Mont-de-Marsan, 40024, France

Location

Centre d'oncologie de Gentilly

Nancy, France

Location

Centre Catherine de Sienne

Nantes, France

Location

Centre Antoine Lacassagne

Nice, France

Location

Centre Hospitalier Régional

Orléans, France

Location

Institut Curie - Hopital Claudius Régaud

Paris, 75005, France

Location

Hôpital Cochin

Paris, 75014, France

Location

Groupe Hospitalier Saint-Joseph

Paris, 75674, France

Location

Centre Catalan d'Oncologie

Perpignan, 66000, France

Location

Centre Hospitalier Lyon-sud

Pierre-Bénite, 69495, France

Location

Centre Hospitalier de la Région d'Annecy

Pringy, 74374, France

Location

Clinique Courlancy

Reims, 51100, France

Location

Institut Jean Godinot

Reims, France

Location

Centre Henri Becquerel

Rouen, France

Location

Anne-Claire Hardy-Bessard, MD

Saint-Brieuc, 22015, France

Location

Clinique Armoricaine de Radiologie

Saint-Brieuc, France

Location

Centre Hospitalier Privé de Saint-Grégoire

Saint-Grégoire, 35760, France

Location

GHPSO - Site Senlis

Senlis, 60309, France

Location

Centre de Radiothérapie - Clinique Sainte-Anne

Strasbourg, 67000, France

Location

Centre Hospitalier de Thonon-les-Bains

Thonon-les-Bains, 74203, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

CHU Bretonneau

Tours, France

Location

Centre Hospitalier de Valence

Valence, 26953, France

Location

Centre Hospitalier Bretagne Atlantique

Vannes, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

eribulin; Bevacizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Anne-Claire HARDY-BESSARD, MD

  Clinique Armoricaine de Radiologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2013
• First Posted: September 13, 2013
• Study Start: November 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: March 1, 2016
• Last Updated: March 17, 2016

Record last verified: 2016-03

Locations

FR (40)