ZD1839 (Iressa™) In Combination With Docetaxel As First-Line Treatment In Patients With Metastatic Breast Cancer

Inclusion Criteria: * Histologically or cytologically confirmed breast cancer at a metastatic stage. * Uni- or bi-dimensionally measurable lesions (10 mm or 20 mm) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria * World Health Organisation (WHO) performance status (PS) of 0 to 2 * Life expectancy of greater than 12 weeks * Normal cardiac function (left ventricular ejection fraction \[LVEF\] by isotopic examination greater than or equal to 55%) Exclusion Criteria: * Symptomatic lepto-meningeal metastasis * Concomitant infectious disease * Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy * Incomplete healing from previous oncologic or other surgery * Absolute neutrophil count (ANC) less than 1.5 x 109/litre (L) or platelets less than 100 x 109/L * Serum creatinine greater than 1.5 times the ULRR or clearance \< 60 ml/min * ALT or AST greater than 2.5 times the ULRR * ALP \> 5 times the ULRR * ALP \> 2.5 times the ULRR and ALT or AST greater than 1.5 times the ULRR