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Whether Human Epidermal growth factor Receptor 2 (HER2)-low status has prognostic significance in HR + /HER2- advanced Breast Cancer (aBC) patients treated with first-line Endocrine Therapy plus CDK 4/6 inhibitors remains unclear. In 428 patients evaluated, HER2-low status was independently associated with significantly worse PFS and OS when compared with HER2-0 status. Based on our findings, HER2-low status could become a new prognostic biomarker in this clinical setting., SCOPUS: ar.j, info:eu-repo/semantics/published

Maria Chiara Parati,1 Rebecca Pedersini,2 Gianluca Perego,3 Roberto Reduzzi,4 Tommaso Savio,4 Mary Cabiddu,1 Karen Borgonovo,1 Mara Ghilardi,1 Andrea Luciani,1 Fausto Petrelli1 1Oncology Unit, Medical Science Department, ASST Bergamo Ovest, Treviglio, BG, Italy; 2Breast Unit-Medical Oncology, ASST Spedali Civili, Brescia, Italy; 3Pharmacy Unit, IRCCS San Raffaele Hospital, Milan, Italy; 4Breast Unit, ASST Bergamo Ovest, Treviglio, BG, ItalyCorrespondence: Fausto Petrelli, Oncology Unit, Medical Sciences Department, ASST Bergamo Ovest, Piazzale Ospedale 1, Treviglio, 24047, BG, Italy, Tel +390363424420, Fax +390363424380, Email faupe@libero.itAbstract: Among pre- and postmenopausal women with hormone receptor-positive (HR+) breast cancer (BC), combinations of an aromatase inhibitor (AI) or fulvestrant with a CDK 4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) have demonstrated improved progression-free survival (PFS) and overall survival (OS) compared to standard single-agent hormone therapy alone as first-line therapy for de novo metastatic disease or relapse during or after adjuvant therapy and no previous therapies in an advanced setting. We here reviewed clinical data about ribociclib in advanced and early BC. Also, we shed light on patient selection and special settings in which medical oncologists urgently await an advance in treatment. Ribociclib was FDA-approved in combination with letrozole based on a Phase III study in which 668 postmenopausal women with HR+, HER2-negative recurrent or metastatic BC were treated with first-line letrozole with or without ribociclib. For patients with metastatic disease at presentation or after a course of AIs, the results of the MONALEESA-3 trial suggest ribociclib’s efficacy in combination with fulvestrant, and this combination is FDA-approved for initial- and subsequent-line endocrine therapy for postmenopausal women with metastatic hormone receptor-positive, HER2-negative BC. In adjuvant and neoadjuvant settings