Status:
COMPLETED
ZD1839 (Iressa™) In Combination With Docetaxel As First-Line Treatment In Patients With Metastatic Breast Cancer
Lead Sponsor:
AstraZeneca
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00247481
Start Date
September 1 2002
End Date
June 1 2005
Last Update
April 23 2009
Active Locations (5)
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1
Research Site
Dijon, France
2
Research Site
Paris, France
3
Research Site
Saint-Cloud, France
4
Research Site
Saint-Germain-en-Laye, France