This is a phase II, multicenter, double-blind, randomized, placebo-controlled trial. Patients will be randomized in a double-blind manner in a 1:1 ratio to receive either 250 mg/day ZD1839 or matched placebo in combination with 1 mg/day anastrozole. The dose of ZD1839 has been selected based on clinical studies in other tumor types suggesting identical efficacy together with a better toxicity profile in patients treated at 250 mg compared to 500 mg/day. The 1 mg dose of anastrozole is the standard approved dose.
Inclusion Criteria: * Female postmenopausal patients aged 18 years or older with newly diagnosed metastatic breast cancer. * Patients with recurrent disease during or after adjuvant tamoxifen or patients who are hormone therapy naïve are eligible for this trial. * A paraffin embedded tumor tissue block or slides from either the metastatic or primary tumor site is required. Exclusion Criteria: * Patients cannot be on hormone replacement therapy while on study. * Prior chemotherapy received for metastatic disease is not allowed. * Previous treatment with tyrosine kinase inhibitors or aromatase inhibitors is not allowed. * Patients who have evidence of an active interstitial lung disease are not eligible.
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