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Clinical Trials/EUCTR2013-001710-15-FR
EUCTR2013-001710-15-FRActive, not recruitingPhase 1

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

ARCAGY-GINECO0 sites59 target enrollmentStarted: June 3, 2013Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
59
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility 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 < 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

Investigators

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