Ribociclib plus Endocrine Therapy in Early Breast Cancer

Slamon D, Lipatov O, Nowecki Z, McAndrew N, Kukielka-Budny B, Stroyakovskiy D, Yardley DA, Huang CS, Fasching P, Crown J, Bardia A, Chia S, Im SA, Ruiz-Borrego M, Loi S, Xu B, Hurvitz S, Barrios C, Untch M, Moroose R, Visco F, Afenjar K, Fresco R, Severin I, Ji Y, Ghaznawi F, Li Z, Zarate JP, Chakravartty A, Taran T, Hortobagyi G (2024)

Publication Type: Journal article

Publication year: 2024

Journal

Book Volume: 390

Pages Range: 1080-1091

Journal Issue: 12

DOI: 10.1056/NEJMoa2305488

Abstract

Background 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.)

Authors with CRIS profile

Involved external institutions

University of Texas MD Anderson Cancer Center United States (USA) (US) LACOG - Latin American Cooperative Oncology Group Brazil (BR) Peking Union Medical College Hospital (PUMCH) / Beijing Xiehe Hospital China (CN) Columbian College of Arts and Sciences United States (USA) (US) Moscow City Oncology Hospital №62 Russian Federation (RU) HELIOS Kliniken Germany (DE) Veterans Affairs Healthcare System Boston and Harvard Medical School United States (USA) (US) Orlando Health United States (USA) (US) Republican Oncological Clinical Dispensary / Республиканский клинический онкологический диспансер Russian Federation (RU) Seoul National University (SNU) / 서울대학교 Korea, Republic of (KR) St Vincent's University Hospital Ireland (IE) Maria Skłodowska-Curie Institute of Oncology / Centrum Onkologii–Instytut im. Marii Skłodowskiej-Curie w Warszawie Poland (PL) Hospitales Universitarios Virgen Macarena y Virgen del Rocío Spain (ES) British Columbia Cancer Agency Canada (CA) Sarah Cannon Research Institute (SCRI) United States (USA) (US) University of Washington United States (USA) (US) University of California Los Angeles (UCLA) United States (USA) (US) Novartis AG Switzerland (CH) Peter MacCallum Cancer Centre Australia (AU) National Taiwan University Hospital (NTUH) / 國立台灣大學醫學院附設醫院 Taiwan (TW) Lublin Oncology Center / Centrum Onkologii Ziemi Lubelskiej (COZL) Poland (PL)

How to cite

APA:

Slamon, D., Lipatov, O., Nowecki, Z., McAndrew, N., Kukielka-Budny, B., Stroyakovskiy, D.,... Hortobagyi, G. (2024). Ribociclib plus Endocrine Therapy in Early Breast Cancer. New England Journal of Medicine, 390(12), 1080-1091. https://doi.org/10.1056/NEJMoa2305488

MLA:

Slamon, Dennis, et al. "Ribociclib plus Endocrine Therapy in Early Breast Cancer." New England Journal of Medicine 390.12 (2024): 1080-1091.

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