NCT01303679

1st Line Treatment of Bevacizumab-Taxane vs Bevacizumab-Exemestane in Metastatic Breast Cancer

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.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: ARCAGY/ GINECO GROUP · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In first-line metastatic breast cancer, the bevacizumab-taxane to progression or toxicity, is currently the standard treatment. In patients expressing hormone receptors, it was shown that hormone therapy administered in maintenance after induction chemotherapy, could have a benefit regarding the progression-free survival. The investigators make the hypothesis that there would be interest to discontinue treatment with taxane after 4 months, and to begin hormone therapy while continuing maintenance bevacizumab. Exemestane was chosen because it has been shown potentially active in patients who progressed after letrozole, anastrozole or tamoxifen.

Conditions

• First Line Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel	IV, 80mg/m² at d1, d8, d15
DRUG	Bevacizumab	IV, 10 mg/kg at d1, d15 or IV, 15 mg/kg every 3 weeks
DRUG	Exemestane	daily 25 mg (1 pill) oral intake

Timeline

• Start date: 2010-06-01
• Primary completion: 2014-06-01
• Completion: 2018-05-01
• First posted: 2011-02-25
• Last updated: 2023-09-06

Locations

1 site across 1 country: France