"Three anticancer therapeutics that target cell-cycle mediators CDK4 and CDK6, so-called CDK4/6 inhibitors, have been approved by the FDA for use in combination with hormonal drugs, either aromatase inhibitors or fulvestrant, for treating postmenopausal women with HR-positive, HER2-negative advanced breast cancer", said Debu Tripathy, MD, Professor of Medicine and Chair of the Department of Breast Medical Oncology at The University of Texas MD Anderson Cancer Center in Houston.
MONALEESA-7 is a phase III randomized, double-blind, placebo-controlled trial investigating the efficacy and safety of Kisqali in combination with oral hormonal therapies and goserelin versus endocrine treatment alone in premenopausal or perimenopausal women with HR+/HER2- advanced breast cancer who had not previously received endocrine therapy for advanced disease.
The MONALEESA-7 trial met its primary endpoint of progression-free survival in premenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative advanced breast cancer. Neither adapted DFS nor OS differed between the groups in multivariate analyses adjusted for patient and tumor variables and chemotherapy (hazard ratio [HR] for DFS, 0.97; 95% CI: 0.75-1.25; P =.8; HR for OS, 0.98; 95% CI: 0.67-1.42; P =.9).
Data are available for some of the secondary endpoints.
OUTLINE: Patients are randomized to 1 of 2 cohorts. Adverse events leading to permanent discontinuation of treatment occurred in 4 percent of patients in the ribociclib arm compared with 3 percent in the placebo arm. Ribociclib is beneficial for pre- and perimenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer, according to a study presented at the annual San Antonio Breast Cancer Symposium, held from December 5 to 9 in Texas.