Key clinical point: Capivasertib-fulvestrant therapy demonstrated significant progression-free survival (PFS) benefit and a manageable safety profile in patients with endocrine therapy-resistant hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC).
Major finding: Significant PFS benefits were observed with capivasertib+fulvestrant vs placebo+fulvestrant in the overall population (hazard ratio for progression or death 0.60; P < .001) and in patients with AKT pathway-altered (PIK3CA, AKT1, or PTEN) tumors (hazard ratio 0.50; P < .001). Diarrhea and rash were the most common adverse events in the capivasertib+fulvestrant group.
Study details: Findings are from a primary analysis of the phase 3 CAPItello-291 study including 708 patients with HR+/HER2− advanced BC who had progressed on an aromatase inhibitor with or without cyclin-dependent kinase 4 and 6 inhibitor and were randomly assigned to receive fulvestrant with capivasertib or placebo.
Disclosures: This study was supported by AstraZeneca and other sources. Four authors declared being employees and stockholders in AstraZeneca. Some authors declared having ties with several sources.
Source: Turner NC et al for the CAPItello-291 Study Group. Capivasertib in hormone receptor-positive advanced breast cancer. N Engl J Med. 2023;388(22):2058-2070 (Jun 1). doi: 10.1056/NEJMoa2214131