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.