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
2 other identifiers
interventional
77
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 breast-cancer
Started Sep 2002
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 1, 2005
CompletedFirst Posted
Study publicly available on registry
November 2, 2005
CompletedApril 23, 2009
April 1, 2009
November 1, 2005
April 22, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To estimate the overall response rates (complete response [CR] and partial response [PR]) in the ZD1839-treated group and the placebo-treated group.
Secondary Outcomes (4)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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%)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (5)
Research Site
Dijon, France
Research Site
Paris, France
Research Site
Saint-Cloud, France
Research Site
Saint-Germain-en-Laye, France
Research Site
Villejuif, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca France Medical Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 1, 2005
First Posted
November 2, 2005
Study Start
September 1, 2002
Study Completion
June 1, 2005
Last Updated
April 23, 2009
Record last verified: 2009-04