First Line Metastatic Breast Cancer Treatment (ESMERALDA)

Phase 2

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: Eribulin

• Registration Number: NCT01941407
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-10
• Study First Submitted QC: 2013-09-10
• Study First Posted: 2013-09-13
• Study Start: 2013-11
• Primary Completion: 2014-08
• Status Verified: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-03-15
• Last Update Posted: 2016-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 61

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Association eribulin and bevacizumab	Eribulin	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

Primary Outcome Measures

Name	Time	Method
Number of patient with non progressive disease	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

Name	Time	Method
Toxicity based on the CTCAE v4.03 criteria	12 months

Trial Locations

Locations (40)

Centre Paul Papin; 🇫🇷 Angers, France

Centre Hospitalier d'Auxerre; 🇫🇷 Auxerre, France

Institut Ste Catherine; 🇫🇷 Avignon, France

Clinique Tivoli; 🇫🇷 Bordeaux, France

Hôpital Fleyriat; 🇫🇷 Bourg-en-Bresse, France

Hôpital Morvan - Centre Hospitalier Universitaire; 🇫🇷 Brest, France

centre Francois baclesse; 🇫🇷 Caen, France

Hôpital Privé Sainte-Marie; 🇫🇷 Chalon sur Saône, France

Centre Hospitalier William Morey; 🇫🇷 Chalon sur Saône, France

Centre d'Oncologie et de Radiothérapie; 🇫🇷 Dijon, France

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