Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer

Dennis J Slamon, Patrick Neven, Stephen Chia, Peter A Fasching, Michelino De Laurentiis, Seock-Ah Im, Katarina Petrakova, Giulia V Bianchi, Francisco J Esteva, Miguel Martín, Arnd Nusch, Gabe S Sonke, Luis De la Cruz-Merino, J Thaddeus Beck, Xavier Pivot, Manu Sondhi, Yingbo Wang, Arunava Chakravartty, Karen Rodriguez-Lorenc, Tetiana TaranGuy Jerusalem

Research output: Contribution to journalArticlepeer-review


BACKGROUND: In an earlier analysis of this phase 3 trial, ribociclib plus fulvestrant showed a greater benefit with regard to progression-free survival than fulvestrant alone in postmenopausal patients with hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. Here we report the results of a protocol-specified second interim analysis of overall survival.

METHODS: Patients were randomly assigned in a 2:1 ratio to receive either ribociclib or placebo in addition to fulvestrant as first-line or second-line treatment. Survival was evaluated by means of a stratified log-rank test and summarized with the use of Kaplan-Meier methods.

RESULTS: This analysis was based on 275 deaths: 167 among 484 patients (34.5%) receiving ribociclib and 108 among 242 (44.6%) receiving placebo. Ribociclib plus fulvestrant showed a significant overall survival benefit over placebo plus fulvestrant. The estimated overall survival at 42 months was 57.8% (95% confidence interval [CI], 52.0 to 63.2) in the ribociclib group and 45.9% (95% CI, 36.9 to 54.5) in the placebo group, for a 28% difference in the relative risk of death (hazard ratio, 0.72; 95% CI, 0.57 to 0.92; P = 0.00455). The benefit was consistent across most subgroups. In a descriptive update, median progression-free survival among patients receiving first-line treatment was 33.6 months (95% CI, 27.1 to 41.3) in the ribociclib group and 19.2 months (95% CI, 14.9 to 23.6) in the placebo group. No new safety signals were observed.

CONCLUSIONS: Ribociclib plus fulvestrant showed a significant overall survival benefit over placebo plus fulvestrant in patients with hormone-receptor-positive, HER2-negative advanced breast cancer. (Funded by Novartis; MONALEESA-3 ClinicalTrials.gov number, NCT02422615.).

Original languageEnglish
Pages (from-to)514-524
Number of pages11
JournalThe New England journal of medicine
Issue number6
Publication statusPublished - Feb 6 2020


  • Aged
  • Aminopyridines/administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols/adverse effects
  • Breast Neoplasms/drug therapy
  • Drug Administration Schedule
  • Female
  • Fulvestrant/administration & dosage
  • Humans
  • Kaplan-Meier Estimate
  • Middle Aged
  • Postmenopause
  • Progression-Free Survival
  • Purines/administration & dosage
  • Receptor, ErbB-2
  • Receptors, Estrogen
  • Receptors, Progesterone


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