THURSDAY, March 21, 2024 (HealthDay News) -- Ribociclib plus a nonsteroidal aromatase inhibitor (NSAI) significantly improves invasive disease-free survival among patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer, according to a study published in the March 21 issue of the New England Journal of Medicine.
Dennis Slamon, M.D., Ph.D., from the David Geffen School of Medicine at the University of California in Los Angeles, and colleagues conducted a phase 3 trial in which patients with HR-positive, HER2-negative early breast cancer were randomly assigned (1:1) to receive ribociclib (400 mg per day for three weeks, followed by one week off, for three years) plus an NSAI (letrozole [2.5 mg per day] or anastrozole [1 mg per day] for at least five years) or an NSAI alone.
The researchers observed a significant invasive disease-free survival benefit with ribociclib plus an NSAI versus an NSAI alone. Invasive disease-free survival at three years was 90.4 percent with ribociclib plus an NSAI versus 87.1 percent with an NSAI alone (hazard ratio for invasive disease, recurrence, or death, 0.75). For distant disease-free survival and recurrence-free survival, results also favored ribociclib plus an NSAI. No new safety signals emerged.
"These results support the use of ribociclib in the treatment of HR-positive, HER2-negative early breast cancer," the authors write.
The study was funded by Novartis, the manufacturer of ribociclib.
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