MONALEESA-2
Regimen
- Experimental
- Ribociclib 600 mg daily (3 weeks on, 1 week off) plus letrozole 2.5 mg daily.
- Control
- Placebo plus letrozole 2.5 mg daily.
Population
Postmenopausal women with HR+/HER2- advanced breast cancer and no prior systemic therapy for advanced disease.
Key finding
MONALEESA-2 established ribociclib plus letrozole in 1L postmenopausal HR+/HER2- metastatic disease. The 2022 final OS analysis showed a 12.5-month median OS improvement -- the first clear OS win for a CDK4/6 inhibitor in 1L postmenopausal, shaping current NCCN preference for ribociclib in this setting.
Source: PMID 27717303
Timeline
- Publication: 2016 Nov 3
Guideline citations
- NCCN BREAST