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The New England Journal of MedicineRibociclib plus Endocrine Therapy in Early Breast Cancer

A Look Into Ribociclib’s Impact on Early Breast Cancer

This study investigates the efficacy of ribociclib, in combination with a nonsteroidal aromatase inhibitor (NSAI), in improving invasive disease–free survival in patients with HR-positive, HER2-negative early breast cancer. By extending the research from advanced to early-stage breast cancer, the trial offers valuable insights into the potential broader applicability of ribociclib in oncological treatment.

Study Design:

  • Type: International, open-label, randomized, phase 3 trial.
  • Participants: Patients with HR-positive, HER2-negative stage II or III early breast cancer.
  • Intervention: Ribociclib (400 mg/day for 3 weeks, followed by 1 week off, for 3 years) plus NSAI (letrozole or anastrozole for ≥5 years). Premenopausal women and men also received goserelin.
  • Primary endpoint: Invasive disease–free survival.
  • Analysis: Kaplan–Meier method and stratified log-rank test.

Key Findings:

  • Invasive disease–free survival at 3 years: 90.4% with ribociclib plus NSAI vs. 87.1% with NSAI alone.
  • Hazard ratio for invasive disease, recurrence, or death: 0.75; 95% CI, 0.62 to 0.91; P=0.003.
  • Secondary endpoints (distant disease–free survival and recurrence-free survival) also favored the ribociclib combination.
  • No new safety signals were identified with the ribociclib regimen.

According to the World Health Organization, breast cancer is the most common cancer among women worldwide, impacting 2.1 million women each year.

More on Breast Cancer

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