Trial Information
Phase III Randomized Multicenter Trial Comparing Continued Maintenance Therapy With the Bevacizumab + Taxane Versus Bevacizumab + Substituting Exemestane in Patients With Metastatic Breast Cancer or Locally Advanced With Estrogen Receptor Positive and Having at Least a Stable Disease After 16 to 18 Weeks of Treatment With Bevacizumab + Taxane.
Inclusion Criteria:
- Age > 18 ans.
- Metastatic breast cancer or locally advanced
- RE+, HER2-
- Patient receiving paclitaxel-bevacizumab first line chemotherapy
Exclusion Criteria:
- Previous treatment by exemestane (both in adjuvant or metastatic treatment).
- 1st line of chemotherapy different thaan paclitaxel-bevacizumab.
- Treatment by paclitaxel-bevacizumab > 18 weeks.
- HER2 positifs et/ou récepteurs aux oestrogènes négatifs.
- Previous thrombosis event within the 6 months before inclusion .
- Previous significant surgery within the 28 days before treatment start
- Previuous coagulopathy.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Primary free survival
Outcome Time Frame:
24 months for recruitment and 18 months for follow up
Safety Issue:
No
Principal Investigator
Thomas BACHELOT, Md
Investigator Role:
Principal Investigator
Investigator Affiliation:
GINECO
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
Arobase (GINECO-BR107)
NCT ID:
NCT01303679
Start Date:
June 2010
Completion Date:
May 2018
Related Keywords:
- First Line Metastatic Breast Cancer
- First line metastatic breast cancer
- Positive estrogen receptors
- Negative HER2 receptors
- At least stable disease after 4 months of paclitaxel-bevcizumab induction chemotheray
- Breast Neoplasms