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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00247481

Enrollment

Registered

2005-11-02

Start date

2002-09-30

Completion date

2005-06-30

Last updated

2009-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Metastatic Breast Cancer

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.

Interventions

DRUGGefitinib

DRUGDocetaxel

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	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	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026