Patients were stratified by the presence or absence of lung or liver metastases and prior endocrine therapy (treatment-naïve in the advanced setting vs having received up to one line of endocrine therapy for advanced disease). The primary end point was locally assessed PFS using RECIST v1.1. Secondary end points included OS, ORR, clinical benefit rate, and safety and tolerability.1-3
1L, first line; 2L, second line; aBC, advanced breast cancer; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; QoL, quality of life; RECIST, Response Evaluation Criteria In Solid Tumors.
References: 1. KISQALI [Summary of Product Characteristics]. Novartis Pharma AG; 2019. 2. Slamon DJ, Neven P, Chia S, et al. Phase III randomized study of ribociclib and fulvestrant in hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer: MONALEESA-3. J Clin Oncol. 2018;36(24):2465-2472. 3. Slamon DJ, Neven P, Chia S, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer [published online December 11, 2019]. N Engl J Med. doi:10.1056/NEJMoa1911149.