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Ribociclib Plus Endocrine Therapy for Early Breast Cancer
abstract
This abstract is available on the publisher's site.
Access this abstract nowBACKGROUND
Ribociclib has been shown to have a significant overall survival benefit in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. Whether this benefit in advanced breast cancer extends to early breast cancer is unclear.
METHODS
In this international, open-label, randomized, phase 3 trial, we randomly assigned patients with HR-positive, HER2-negative early breast cancer in a 1:1 ratio to receive ribociclib (at a dose of 400 mg per day for 3 weeks, followed by 1 week off, for 3 years) plus a nonsteroidal aromatase inhibitor (NSAI; letrozole at a dose of 2.5 mg per day or anastrozole at a dose of 1 mg per day for ≥5 years) or an NSAI alone. Premenopausal women and men also received goserelin every 28 days. Eligible patients had anatomical stage II or III breast cancer. Here we report the results of a prespecified interim analysis of invasive disease-free survival, the primary end point; other efficacy and safety results are also reported. Invasive disease-free survival was evaluated with the use of the Kaplan-Meier method. The statistical comparison was made with the use of a stratified log-rank test, with a protocol-specified stopping boundary of a one-sided P-value threshold of 0.0128 for superior efficacy.
RESULTS
As of the data-cutoff date for this prespecified interim analysis (January 11, 2023), a total of 426 patients had had invasive disease, recurrence, or death. A significant invasive disease-free survival benefit was seen with ribociclib plus an NSAI as compared with an NSAI alone. At 3 years, invasive disease-free survival was 90.4% with ribociclib plus an NSAI and 87.1% with an NSAI alone (hazard ratio for invasive disease, recurrence, or death, 0.75; 95% confidence interval, 0.62 to 0.91; P = 0.003). Secondary end points - distant disease-free survival and recurrence-free survival - also favored ribociclib plus an NSAI. The 3-year regimen of ribociclib at a 400-mg starting dose plus an NSAI was not associated with any new safety signals.
CONCLUSIONS
Ribociclib plus an NSAI significantly improved invasive disease-free survival among patients with HR-positive, HER2-negative stage II or III early breast cancer. (Funded by Novartis; NATALEE ClinicalTrials.gov number, NCT03701334.).
Additional Info
Ribociclib plus Endocrine Therapy in Early Breast Cancer
N. Engl. J. Med 2024 Mar 21;390(12)1080-1091, D Slamon, O Lipatov, Z Nowecki, N McAndrew, B Kukielka-Budny, D Stroyakovskiy, DA Yardley, CS Huang, PA Fasching, J Crown, A Bardia, S Chia, SA Im, M Ruiz-Borrego, S Loi, B Xu, S Hurvitz, C Barrios, M Untch, R Moroose, F Visco, K Afenjar, R Fresco, I Severin, Y Ji, F Ghaznawi, Z Li, JP Zarate, A Chakravartty, T Taran, G HortobagyiFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.