1st Line Treatment of Bevacizumab-Taxane vs Bevacizumab-Exemestane in Metastatic Breast Cancer
- Sponsor
- ARCAGY/ GINECO GROUP
- Study ID
- NCT01303679
- Phase
- PHASE3
- Status
- Terminated
Conditions
- First Line Metastatic Breast Cancer
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Paclitaxel — DRUGIV, 80mg/m² at d1, d8, d15
- Bevacizumab — DRUGIV, 10 mg/kg at d1, d15 or IV, 15 mg/kg every 3 weeks
- Exemestane — DRUGdaily 25 mg (1 pill) oral intake
Study Details
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.
Key Dates
- First listed
- Feb 25, 2011
- Start date
- Jun 30, 2010
- Status verified
- Sep 2023
- Primary completion
- Jun 30, 2014
- Completion
- May 31, 2018
Study Design
- Enrollment
- 117 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: paclitaxel-bevacizumabPaclitaxel, 80mg/m² at d1, d8, d15 bevacizumab, 10 mg/kg at d1, d15
- Experimental: exemestane-bevacizumabexemestane, 25 mg daily dose bevacizumab, 15mg/kg every 3 weeks
Primary Outcome Measure
Primary free survival [ Time Frame: 24 months for recruitment and 18 months for follow up ]