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

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Docetaxel; Gefitinib

Criteria

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