FDA approved ribociclib in combination with an AI as initial endocrine-based therapy for the treatment of postmenopausal women (in 2017) and pre/perimenopausal woman with HR-positive HER2-negative advanced or metastatic BC (in 2018) according to results of the two phase 3 trials, MONALEESA-2 [68] and MONALEESA-7, respectively [69]. This evidence concerns the gene ERBB2 and breast cancer.