Phase II study in patient in first line for HER - metastasis breast cancer treated with eribulin and bevacizumab

Phase 1

• Conditions: Patient with breast adenocarcinoma; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2013-001710-15-FR
• Lead Sponsor: ARCAGY-GINECO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-03
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 59

Inclusion Criteria

Patient with a metastasis breast adenocarcinoma, based on histology
Positives or negatives hormonal RP and RE receptors, HER 2 negativ, with prersence of at least one mesurable lesion.
Biology as follow :
Neutrophils > 1,5 x 109/L
Platelets > 100 x 109/L
Hémoglobin > 9,0 g/dL
Bilirubin < 1,5 LSN (Limite Supérieure Normale)
Transaminases (ASAT et ALAT et PAL) < 1,5 x upper limit for patient without hepatic metastasis hépatiques et and < 3 if hepatic metastasis
Age > 18 ans.
Availabilty to follows the protocole's rules.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

Exclusion Criteria

Previous chemotherapy
Previoulsy treated with eribulin or bevacizumab
brain metastasis
previous cancer ( exept cancer treated with no relase within the 5 years before the start of the study)
Participation in another study within the previous 30 days

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: evaluate the rate of non progressive patients at 12 months, -( control rate or non progressive rate)<br><br> The desease controle rate will be evaluate with RECIST criteria1.1.<br> ;<br> Secondary Objective: objective response rate<br> Progression free survival<br> Overall survival<br> Toxicity<br> Quality of life<br> ;Primary end point(s): Progression free survival at 1 year ( RECIST 1.1 );<br> Timepoint(s) of evaluation of this end point: CA125 at each cycle<br> CT scan at baseline and every 3 months<br>

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): Objective response rate<br> overall survival<br> Toxicity<br> quality of life<br> ;Timepoint(s) of evaluation of this end point: quality of life questionnaires