MONALEESA-3

NCT02422615 📎

Regimen

Experimental
Ribociclib 600 mg daily (3/1 schedule) plus fulvestrant 500 mg.
Control
Placebo plus fulvestrant 500 mg.

Population

Postmenopausal women or men with HR+/HER2- advanced breast cancer, either 1L or early 2L (up to 1 prior endocrine therapy).

Key finding

MONALEESA-3 established ribociclib plus fulvestrant as an OS-improving option in postmenopausal HR+/HER2- 1L or early 2L metastatic disease, and also accommodated men. Consistent with MONALEESA-2/-7 OS benefits, it reinforced the CDK4/6-class OS signal for ribociclib specifically.

Source: PMID 29860922

Timeline

  • Publication: 2018 Aug 20

Guideline citations

  • NCCN BREAST