Gabriel N. Hortobagyi, MD, professor of medicine, chair, Department of Breast Medical Oncology, director, Multidisciplinary Breast Cancer Research Program, University of Texas MD Anderson Cancer Center, discusses the BOLERO-2 trial that examined everolimus (Afinitor) plus exemestane (Aromasin) in hormone receptor-positive (HR+) breast cancer.

The trial was a prospective, double blind, placebo-controlled, phase III trial examining 724 postmenopausal women with HR+ metastatic breast cancer that had previously been treated with an aromatase inhibitor such as anastrozole or letrozole. Patients were randomized 2:1 to receive exemestane plus everolimus or exemestane plus placebo.

At the median follow-up of 12.5 months the progression-free survival (PFS) was 7.4 months for the everolimus arm and 3.2 in the control arm. The hazard ratio was 0.44 with a highly significant P-value. At this point it is too early to determine an overall-survival benefit.

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