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

Phase 2

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00247481
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09
• Study Completion: 2005-06
• Study First Submitted: 2005-11-01
• Study First Submitted QC: 2005-11-01
• Study First Posted: 2005-11-02
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-22
• Last Update Posted: 2009-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 77

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇫🇷 Villejuif Cedex, France