Dr. Neven on the Design of the MONALEESA-3 Trial in Advanced Breast Cancer

Patrick Neven, MD, Universitair Ziekenhuis Leuven, Belgium, outlines the design of the phase III MONALEESA-3 trial in hormone receptor—positive, HER2-negative advanced breast cancer.

The multicenter, randomized, double-blind trial sought to improve the outcomes of this postmenopausal patients with HR-positive, HER2-negative advanced disease who received either no lines or only 1 prior line of endocrine treatment. The primary end point of the trial was progression-free survival (PFS) and overall survival (OS) served as a secondary end point, says Neven.

In the trial, patients were randomized to receive either ribociclib (Kisqali) in combination with fulvestrant (Faslodex) or fulvestrant plus placebo. Results showed a significant improvement in PFS with ribociclib/fulvestrant compared with fulvestrant/placebo. Furthermore, at a median follow-up of 39.4 months, the ribociclib combination showed a statistically significant prolongation in OS compared with fulvestrant/placebo.