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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: November 1, 2005
Last updated: April 22, 2009
Last verified: April 2009
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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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:

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

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00247481

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
Study Director: AstraZeneca France Medical Director, MD AstraZeneca
  More Information Identifier: NCT00247481     History of Changes
Other Study ID Numbers: D7913C00148
Study First Received: November 1, 2005
Last Updated: April 22, 2009

Keywords provided by AstraZeneca:
Metastatic Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors processed this record on May 25, 2017