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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001710-15-FR

Enrollment

Registered

2013-06-03

Start date

2013-07-19

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient with breast adenocarcinoma

Interventions

Trade Name: HALAVEN Product Name: Halaven Product Code: eribulin Pharmaceutical Form: Concentrate for solution for injection/infusion T

Eligibility

Sex/Gender

All

Inclusion criteria

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 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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
Secondary end point(s): Objective response rate overall survival Toxicity quality of life ;Timepoint(s) of evaluation of this end point: quality of life questionnaires	—

Countries

France

Contacts

Public ContactMARMION

ARCAGY-GINECO

1 42348323

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026