Primary endpoints of centrally reviewed PFS in all patients (intent-to-treat (ITT) population, n = 477) and in patients with detectable ESR1 mutations from circulating tumor DNA (ctDNA) were met (hazard ratio (HR) 0.70, P = 0.002 and HR 0.55, P = 0.0005, respectively). The gene discussed is ESR1; the disease is neoplasm.