A Phase 3 interventional study of Paclitaxel and Bevacizumab in First Line Metastatic Breast Cancer, sponsored by ARCAGY/ GINECO GROUP. Terminated at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-06.
Sponsored by ARCAGY/ GINECO GROUP · Phase 3, Interventional, and Treatment
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 117 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →ARCAGY/ GINECO GROUP is the lead sponsor of 51 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Paclitaxel, 80mg/m² at d1, d8, d15 bevacizumab, 10 mg/kg at d1, d15
Drug: Paclitaxel · Drug: Bevacizumab
exemestane, 25 mg daily dose bevacizumab, 15mg/kg every 3 weeks
Drug: Bevacizumab · Drug: Exemestane
IV, 80mg/m² at d1, d8, d15
IV, 10 mg/kg at d1, d15 or IV, 15 mg/kg every 3 weeks
daily 25 mg (1 pill) oral intake
Primary free survival
Time frame: 24 months for recruitment and 18 months for follow up
This study is terminated, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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ARCAGY/ GINECO GROUP