NATALEE

NCT03701334 📎

Regimen

Experimental
Ribociclib 400 mg daily (3 weeks on, 1 week off) for 3 years plus standard endocrine therapy (nonsteroidal AI, with goserelin if pre/perimenopausal or male).
Control
Standard endocrine therapy alone (nonsteroidal AI plus goserelin as indicated).

Population

Stage II-III HR+/HER2- early breast cancer at risk of recurrence, including broader node-negative high-risk (stage IIA N0 with grade 3, or grade 2 plus Ki-67 >=20% or high-risk genomic score) and all stage IIB/III.

Key finding

NATALEE extended the adjuvant CDK4/6 inhibitor benefit to a broader population including selected stage II N0 patients, using a lower 400 mg ribociclib dose for 3 years. FDA approved September 2024 for stage II/III HR+/HER2- at high risk of recurrence. NCCN v2.2026 BINV-16 lists ribociclib as an option for eligible patients; see BINV-K 2 for eligibility.

Source: PMID 38507751

Timeline

  • Publication: 2024 Mar 21

Guideline citations

  • NCCN BREAST