Ribociclib Plus Endocrine Therapy for Early Breast Cancer: NATALEE Trial

Rodrigo Arrangoiz MS, MD, FACS, FSSO
  • Practice Guideline:
    • The NATALEE trial was an open-label, multicenter, randomized phase III trial:
      • That evaluated the addition of ribociclib to standard endocrine therapy (ET) in patients with stage II to III hormone receptor-positive, HER2-negative early breast cancer
    • The trial included 2,549 patients receiving ribociclib (400 mg once daily, 3 weeks on, 1 week off) plus ET and 2,552 patients receiving ET alone
    • At a median follow-up of 27.7 months:
      • Ribociclib plus ET significantly improved invasive disease-free survival (IDFS) compared to ET alone (HR, 0.75; 95% CI, 0.62 to 0.91; P = .003), with 3-year IDFS rates of 90.4% versus 87.1%, respectively
      • Additionally, ribociclib plus ET improved distant disease-free survival (DDFS) (HR, 0.74; 95% CI, 0.60 to 0.91)[1]
    • The American Society of Clinical Oncology (ASCO) recommends:
      • Considering ribociclib in combination with ET for patients with stage II to III hormone receptor-positive, HER2-negative early breast cancer:
        • Particularly those with high-risk features
      • This recommendation is based on the significant IDFS benefit observed in the NATALEE trial
      • However, ASCO suggests that ribociclib may not provide meaningful clinical benefit to all eligible patients:
        • Especially those with lower-risk disease, and emphasizes the importance of individual patient factors in decision-making
  • The NATALEE trial was a pivotal phase III study that evaluated the efficacy and safety of ribociclib in combination with endocrine therapy (ET) in patients with stage II to III hormone receptor-positive, HER2-negative early breast cancer
    • The trial included 5,101 patients who were randomized to receive either ribociclib (400 mg/day, 3 weeks on/1 week off for 3 years) plus a nonsteroidal aromatase inhibitor (NSAI) or NSAI alone
    • Premenopausal women and men also received Goserelin
    • The primary endpoint of the trial was invasive disease-free survival (iDFS)
    • At a median follow-up of 33.3 months:
      • Ribociclib plus ET demonstrated a significant improvement in iDFS compared to ET alone:
        • With a hazard ratio (HR) of 0.749 (95% CI, 0.628-0.892; P = 0.0012)
      • The 3-year iDFS rates were 90.7% for the ribociclib plus ET group versus 87.6% for the ET alone group
      • This benefit was consistent across various subgroups, including those with different stages and nodal statuses[2][3][4]
      • Secondary endpoints, such as distant disease-free survival (DDFS) and recurrence-free survival (RFS), also favored the ribociclib plus ET group
      • No new safety signals were observed, and the treatment was generally well-tolerated [2][3][4]
  • Based on the NATALEE trial results, ribociclib in combination with ET is indicated for patients with stage II to III hormone receptor-positive, HER2-negative early breast cancer, particularly those at high risk of recurrence:
    • This includes patients with node-positive disease and those with additional high-risk features
  • The trial’s findings support the use of ribociclib as an effective adjuvant therapy to improve iDFS and reduce the risk of recurrence in this patient population [2][3][4]
  • References:
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Published by Rodrigo Arrangoiz MS, MD, FACS, FSSO

My name is Rodrigo Arrangoiz I am a breast surgeon/ thyroid surgeon / parathyroid surgeon / head and neck surgeon / surgical oncologist that works at Center for Advanced Surgical Oncology in Miami, Florida. I was trained as a surgeon at Michigan State University from (2005 to 2010) where I was a chief resident in 2010. My surgical oncology and head and neck training was performed at the Fox Chase Cancer Center in Philadelphia from 2010 to 2012. At the same time I underwent a masters in science (Clinical research for health professionals) at the University of Drexel. Through the International Federation of Head and Neck Societies / Memorial Sloan Kettering Cancer Center I performed a two year head and neck surgery and oncology / endocrine fellowship that ended in 2016. Mi nombre es Rodrigo Arrangoiz, soy cirujano oncólogo / cirujano de tumores de cabeza y cuello / cirujano endocrino que trabaja Center for Advanced Surgical Oncology en Miami, Florida. Fui entrenado como cirujano en Michigan State University (2005 a 2010 ) donde fui jefe de residentes en 2010. Mi formación en oncología quirúrgica y e n tumores de cabeza y cuello se realizó en el Fox Chase Cancer Center en Filadelfia de 2010 a 2012. Al mismo tiempo, me sometí a una maestría en ciencias (investigación clínica para profesionales de la salud) en la Universidad de Drexel. A través de la Federación Internacional de Sociedades de Cabeza y Cuello / Memorial Sloan Kettering Cancer Center realicé una sub especialidad en cirugía de cabeza y cuello / cirugia endocrina de dos años que terminó en 2016.

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