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

This study has been completed.

First Received: November 1, 2005 Last Updated: April 22, 2009 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00247481

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: Gefitinib Drug: Docetaxel	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Docetaxel ZD1839

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	77
Study Start Date:	September 2002
Study Completion Date:	June 2005

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00247481

Locations

France
Research Site
Dijon, France
Research Site
Paris, France
Research Site
Saint Cloud, France
Research Site
Saint Germain en Laye, France
Research Site
Villejuif Cedex, France

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca France Medical Director, MD

AstraZeneca

More Information

No publications provided

Study ID Numbers:	D7913C00148, 1839IL/0148
Study First Received:	November 1, 2005
Last Updated:	April 22, 2009
ClinicalTrials.gov Identifier:	NCT00247481 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by AstraZeneca:

Metastatic Breast Cancer

Study placed in the following topic categories:

Docetaxel
Skin Diseases
Breast Neoplasms
Gefitinib
Breast Diseases

Additional relevant MeSH terms:

Docetaxel
Neoplasms
Neoplasms by Site
Skin Diseases
Antineoplastic Agents

Therapeutic Uses
Breast Neoplasms
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on September 10, 2009