NATALEE — Ribociclib plus Endocrine Therapy as Adjuvant Treatment in HR-Positive/HER2-Negative Early Breast Cancer

Phase 3 · 2024 · Breast Cancer

Design

Randomized phase 3 to 3 years of adjuvant ribociclib plus a nonsteroidal aromatase inhibitor vs endocrine therapy alone.

Population

HR-positive/HER2-negative stage II-III early breast cancer, including a broader intermediate-risk and selected node-negative population than monarchE.

Primary Endpoint

invasive disease-free survival (iDFS)

Key Result

3-yr iDFS 90.4% vs 87.1% with endocrine therapy alone (HR 0.75); benefit sustained in final iDFS analysis.

Guideline Impact

Adjuvant therapy for HR-positive/HER2-negative early breast cancer