Key clinical point: Ribociclib plus a nonsteroidal aromatase inhibitor (NSAI) vs NSAI alone for 3 years significantly improved invasive disease-free survival in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) early breast cancer (BC).
Major finding: At 3 years, ribociclib + NSAI vs NSAI alone led to a 25.2% lower risk for invasive disease, recurrence, or death (hazard ratio 0.75; two-sided P = .003), with an absolute invasive disease-free survival benefit of 3.3% (90.4% vs 87.1%). No new safety signals were reported.
Study details: This prespecified interim analysis of the phase 3 NATALEE trial included 5101 patients with HR+/HER2− stage II or III early BC who were randomly assigned to receive ribociclib (dosage 400 mg/day for 21 consecutive days followed by 7 days off; duration 36 months) in combination with an NSAI or NSAI alone.
Disclosures: The trial was funded by Novartis. Six authors declared being employees of or holding stocks in Novartis. Several authors declared ties with various sources, including Novartis.
Source: Slamon D, Lipatov O, Nowecki Z, et al. Ribociclib plus endocrine therapy in early breast cancer. N Engl J Med. 2024;390:1080-1091 (Mar 20). doi: 10.1056/NEJMoa2305488 Source