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.
![](https://hcn.health/wp-content/uploads/2023/08/facts-1-1.png)
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