NCT00247481CompletedPhase 2
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 77
- Locations
- 6
- Primary Endpoint
- To estimate the overall response rates (complete response [CR] and partial response [PR]) in the ZD1839-treated group and the placebo-treated group.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
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
- 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
Investigators
Study Sites (6)
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