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)
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Epidermal growth factor receptor inhibitors are believed to overcome/delay breast cancer endocrine resistance.

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Hormone receptor-positive metastatic women were randomized to anastrozole (A) and gefitinib (G) or placebo (P).

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1-Year progression-free survival rate was 35% for A/G and 32% for A/P.

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One-third of G arm patients stopped treatment due to intestinal and skin toxicities.

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Results do not support endocrine resistance delay by adding G to A.

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