Background on the Rationale for the NATALEE Study

  • Patients diagnosed with estrogen receptor (ER)-positive breast cancer receive standard-of-care adjuvant treatment:
    • However, patients can experience disease recurrence:
      • With many recurrences occurring within the first 5 years
  • When disease recurrence does occur, it is often at a more advanced stage when the disease may be incurable:
    • Therefore, it is critical to prevent recurrences to better reach the original curative intent of treatment
  • Prior research demonstrated that ribociclib plus endocrine therapy:
    • Yielded significant improvements in overall and progression-free survival in patients with HR-positive / HER2-negative advanced breast cancer:
      • Based on that, NATALEE was designed to evaluate the combination in patients with early-stage disease
  • Another CDK4/6 inhibitor, abemaciclib, is U.S. Food and Drug Administration (FDA) approved for adjuvant treatment of adult patients with HR-positive / HER2-negative, node-positive early breast cancer at high risk of recurrence
  • What NATALEE now does:
    • If the FDA acknowledges the data for registration:
      • It enlarges the patient population who will have access to a CDK4/6 inhibitor
#Arrangoiz #CancerSurgeon #BreastSurgeon #SurgicalOncologist #BreastCancer #MountSiniaMedicalCenter #MSMC #Miami #Mexico

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