NATALEE
Trial question
What is the role of ribociclib plus a non-steroidal aromatase inhibitor in patients with HR+, HER2- early breast cancer?
Study design
Multi-center
Open label
RCT
Population
5101 patients (5081 female, 20 male).
Inclusion criteria: patients with HR+, HER2- stage II or III early breast cancer.
Key exclusion criteria: receipt of a previous CDK4/6 inhibitor; clinically significant, uncontrolled heart disease, cardiac repolarization abnormalities, or both.
Interventions
N=2549 ribociclib plus NSAI (ribociclib at a dose of 400 mg/day for 3 weeks, followed by 1 week off, for 3 years plus letrozole at a dose of 2.5 mg/day or anastrozole at a dose of 1 mg/day for ≥ 5 years).
N=2552 NSAI alone (letrozole at a dose of 2.5 mg/day or anastrozole at a dose of 1 mg/day for ≥ 5 years).
Primary outcome
Invasive disease-free survival at 3 years
90.4%
87.1%
90.4 %
67.8 %
45.2 %
22.6 %
0.0 %
Ribociclib plus
NSAI
NSAI
alone
Significant
increase ▲
NNT = 30
Significant increase in invasive disease-free survival at 3 years (90.4% vs. 87.1%; HR 1.33, 95% CI 1.1 to 1.61).
Secondary outcomes
Significant increase in distant disease-free survival at 3 years (90.8% vs. 88.6%; HR 1.35, 95% CI 1.1 to 1.67).
Significant increase in recurrence-free survival at 3 years (91.7% vs. 88.6%; HR 1.39, 95% CI 1.14 to 1.72).
No significant difference in overall survival (97.6% vs. 97.1%; HR 1.32, 95% CI 0.93 to 1.85).
Safety outcomes
No significant difference in death.
Conclusion
In patients with HR+, HER2- stage II or III early breast cancer, ribociclib plus NSAI was superior to NSAI alone with respect to invasive disease-free survival at 3 years.
Reference
Dennis Slamon, Oleg Lipatov, Zbigniew Nowecki et al. Ribociclib plus Endocrine Therapy in Early Breast Cancer. N Engl J Med. 2024 Mar 21;390(12):1080-1091.
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