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Ribociclib plus Endocrine Therapy in Early Breast Cancer.

Dennis Slamon1, Oleg Lipatov1, Zbigniew Nowecki1

  • 1From the David Geffen School of Medicine at the University of California, Los Angeles (D. Slamon, N.M.); Republican Clinical Oncology Dispensary, Ufa (O.L.), and Moscow City Oncology Hospital No. 62, Moscow (D. Stroyakovskiy) - both in Russia; Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw (Z.N.), and Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli, Lublin (B.K.-B.) - both in Poland; the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.A.Y.); the National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei City (C.-S.H.); University Hospital Erlangen, the Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen (P.A.F.), and the Interdisciplinary Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - both in Germany; St. Vincent's Hospital, Dublin (J.C.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.B.); the British Columbia Cancer Agency, Vancouver (S.C.), and Translational Research in Oncology (TRIO), Edmonton, AB (I.S.) - both in Canada; the Cancer Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea (S.-A.I.); Hospital Virgen del Rocío, Seville, and Grupo Español de Investigación en Cáncer de Mama, Spanish Breast Cancer Group, Madrid - both in Spain (M.R.-B.); the Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.L.); the Department of Medical Oncology Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (B.X.); the Fred Hutchinson Cancer Center, University of Washington, Seattle (S.H.); the Latin American Cooperative Oncology Group, Porto Alegre, Brazil (C.B.); the Orlando Health Cancer Institute, Orlando, FL (R.M.); the National Breast Cancer Coalition, Washington, DC (F.V.); TRIO, Paris (K.A.); TRIO, Montevideo, Uruguay (R.F.); Novartis Pharmaceuticals, East Hanover, NJ (Y.J., F.G., Z.L., J.P.Z., A.C.); Novartis Pharma, Basel, Switzerland (T.T.); and the Department of Breast Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston (G.H.).

The New England Journal of Medicine
|March 20, 2024
PubMed
Summary

Ribociclib combined with a nonsteroidal aromatase inhibitor (NSAI) significantly improved invasive disease-free survival in patients with early breast cancer. This combination therapy demonstrated a notable benefit for hormone receptor-positive, HER2-negative early breast cancer patients.

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Area of Science:

  • Oncology
  • Pharmacology

Background:

  • Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer shows survival benefit with ribociclib.
  • The efficacy of ribociclib in early-stage disease of the same breast cancer subtype remains to be determined.

Purpose of the Study:

  • To evaluate the efficacy and safety of ribociclib plus a nonsteroidal aromatase inhibitor (NSAI) compared to NSAI alone in patients with HR-positive, HER2-negative early breast cancer.

Main Methods:

  • An international, open-label, randomized phase 3 trial assigned patients with stage II or III HR-positive, HER2-negative early breast cancer to receive ribociclib plus NSAI or NSAI alone for 3 years.
  • Premenopausal women and men also received goserelin. The primary endpoint was invasive disease-free survival (IDFS).

Main Results:

  • At 3 years, IDFS was 90.4% with ribociclib plus NSAI versus 87.1% with NSAI alone (hazard ratio for invasive disease, recurrence, or death, 0.75; P=0.003).
  • Ribociclib plus NSAI also improved secondary endpoints, including distant disease-free survival and recurrence-free survival.
  • No new safety concerns were identified with the 3-year ribociclib plus NSAI regimen.

Conclusions:

  • Ribociclib in combination with an NSAI significantly enhances invasive disease-free survival in patients diagnosed with HR-positive, HER2-negative stage II or III early breast cancer.
  • The NATALEE trial (NCT03701334) provides evidence for this improved outcome in early-stage disease.