MONALEESA-7

NCT02278120 📎

Regimen

Experimental
Ribociclib 600 mg daily (3/1 schedule) plus nonsteroidal AI or tamoxifen plus goserelin (OFS).
Control
Placebo plus nonsteroidal AI or tamoxifen plus goserelin.

Population

Premenopausal or perimenopausal women with HR+/HER2- advanced breast cancer, no prior endocrine therapy for advanced disease (limited prior chemo allowed).

Key finding

MONALEESA-7 was the first CDK4/6 inhibitor trial dedicated to pre/perimenopausal HR+/HER2- metastatic breast cancer and the first to show an OS benefit in this population. Established ribociclib plus endocrine therapy plus OFS as a preferred 1L option for younger women.

Source: PMID 31166679

Timeline

  • Publication: 2019 Jul 25

Guideline citations

  • NCCN BREAST