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news.Novartis' Phase III study of Afinitor (everolimus) tablets plus exemestane, a hormonal therapy, yielded positive results in women with advanced breast cancer.
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BOLERO-2 (Breast cancer trials of OraL EveROlimus-2), a Phase III, randomized, double-blind, placebo-controlled, multicenter study was devised to assess the safety and efficacy of everolimus in combination with exemestane versus exemestane alone in postmenopausal women with ER+HER2- advanced breast cancer.
In the study, patients who met the study criteria were randomized (2:1) to receive either everolimus 10 mg/day orally, or placebo, plus oral exemestane 25 mg/day.
The primary endpoint was progression-free survival (PFS) based on local investigator radiology assessment.
The other endpoints were overall survival, overall response rate, safety, patient reported outcome, clinical benefit rate and changes in markers of bone metabolism.