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news.Novartis' Bolero-2 Phase III double-blind, randomized, multicenter, placebo-controlled study demonstrated that Afinitor (everolimus) tablets plus exemestane more than doubled the time women lived without tumor growth (progression-free survival; PFS).
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The results of the trial also suggested that the combined theraphy also helps in the reduction of the risk of cancer progression by 57% versus exemestane alone in patients with advanced breast cancer.
Data from Bolero-2 support worldwide regulatory submissions, which are planned by the end of 2011.
Bolero-2 study aimed to evaluate the safety and efficacy of everolimus in conjunction with exemestane versus exemestane alone in postmenopausal women with ER+HER2- advanced breast cancer who recurred or progressed while on or following previous treatment with hormonal therapies, letrozole or anastrozole.