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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Gefitinib
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gefitinib|nan|
|Drug: Docetaxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the overall response rates (complete response [CR] and partial response [PR]) in the ZD1839-treated group and the placebo-treated group. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| o To assess progression-free survival (PFS) in the ZD1839-treated group and the placebo-treated group. |  |  | 
| o To estimate the duration of response in the ZD1839-treated group and the placebo treated group |  |  | 
| o To estimate overall survival in the ZD1839-treated group and the placebo-treated group |  |  | 
| o To estimate time to treatment failure (TTF) in the ZD1839-treated group and the placebo treated group |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic Breast Cancer