ZD1839 (Iressa™) In Combination With Docetaxel As First-Line Treatment In Patients With Metastatic Breast Cancer
This study has been completed.
Information provided by:
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
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:
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
|Study Start Date:||September 2002|
|Study Completion Date:||June 2005|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00247481
|Saint Cloud, France|
|Saint Germain en Laye, France|
|Villejuif Cedex, France|
Sponsors and Collaborators
|Study Director:||AstraZeneca France Medical Director, MD||AstraZeneca|