MONARCH-2

NCT02107703 📎

Regimen

Experimental
Abemaciclib 150 mg BID plus fulvestrant 500 mg (OFS if premenopausal).
Control
Placebo plus fulvestrant 500 mg (OFS if premenopausal).

Population

Women with HR+/HER2- advanced breast cancer who had progressed on prior endocrine therapy; premenopausal patients received OFS.

Key finding

MONARCH-2 established abemaciclib plus fulvestrant in post-endocrine-progression HR+/HER2- metastatic disease, with significant PFS and OS benefit. Distinct from palbociclib (PALOMA-3 OS-neutral), it helped differentiate the CDK4/6 class on survival endpoints.

Source: PMID 28580882

Timeline

  • Publication: 2017 Sep 1

Guideline citations

  • NCCN BREAST