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

A Multicentre, Randomised, Double-Blind, Non-Comparative Phase II Trial Of ZD1839 (Iressa™) And Placebo In Combination With Chemotherapy With Docetaxel As First-Line Treatment In Patients With Metastatic Breast Cancer

This is a multicentre, randomised (2:1), double blind, non-comparative phase II trial of ZD1839 and placebo in combination with chemotherapy 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