A European Organisation for Research and Treatment of Cancer randomized, double-blind, placebo-controlled, multicentre phase II trial of anastrozole in combination with gefitinib or placebo in hormone receptor-positive advanced breast cancer (NCT00066378)

•Epidermal growth factor receptor inhibitors are believed to overcome/delay breast cancer endocrine resistance.•Hormone receptor-positive metastatic women were randomized to anastrozole (A) and gefitinib (G) or placebo (P).•1-Year progression-free survival rate was 35% for A/G and 32% for A/P.•One-third of G arm patients stopped treatment due to intestinal and skin toxicities.•Results do not support endocrine resistance delay by adding G to A.