Key clinical point: Palbociclib+fulvestrant prolonged progression-free survival (PFS) compared with placebo+fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, endocrine-sensitive advanced breast cancer (BC).
Major finding: Palbociclib+fulvestrant vs placebo+fulvestrant improved 1-year PFS (83.5% vs 71.9%) and reduced the risk for progressive disease by 45% (hazard ratio [HR], 0.55; 80% CI, 0.36-0.83). Grade 3 or higher adverse events were reported by 80.9% vs 37.9% of patients in palbociclib/fulvestrant vs placebo/fulvestrant arms.
Study details: This was a phase 2 FLIPPER study of 189 postmenopausal women with HR-positive, HER2-negative, endocrine-sensitive advanced BC who were randomly assigned to palbociclib+fulvestrant or placebo+fulvestrant.
Disclosures: This study was funded by GEICAM Spanish Breast Cancer Group, AstraZeneca, and Pfizer. The authors reported receiving research grants, advisory board fees, consulting fees, honoraria, and travel and accommodation support from several sources.
Source: Albanell J et al. Eur J Cancer. 2021 Dec 11. doi: 10.1016/j.ejca.2021.11.010 .