Everolimus trial for breast cancer stopped early; primary endpoint met

An interim analysis of a pivotal phase 3 study showed that everolimus tablets combined with exemestane significantly extended PFS in women with advanced breast cancer, according to a press release from Novartis. The trial was stopped early after results showed the primary endpoint of PFS was met.

The study, BOLERO-2, is a randomized, double blind, placebo-controlled study of everolimus (Afinitor) combined with exemestane vs. placebo plus exemestane in postmenopausal women with ER-positive, HER-2 locally advanced or metastatic breast cancer whose disease has progressed, despite treatment with the nonsteroidal aromatase inhibitors letrozole or anastrozole.

More than 700 patients at more than 195 sites worldwide were randomly assigned 2:1 to receive continuous therapy with everolimus 10 mg per day orally or placebo plus oral exemestane 25 mg per day. Patients who had received more than one prior chemotherapy regimen for advanced breast cancer were excluded from enrollment.

Secondary endpoints included OS, overall response rate, incidence of adverse events, patient reported outcomes and clinical benefit rate. Novartis officials said complete study results will be presented at an upcoming medical conference; regulatory submissions are expected by the end of this year.

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