ZD1839 (Iressa™) In Combination With Docetaxel As First-Line Treatment In Patients With Metastatic Breast Cancer
Status and phase
Completed
Phase 2
Conditions
Breast Cancer
Treatments
Drug: Docetaxel
Drug: Gefitinib
Details and patient eligibility
About
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.
Sex
Female
Ages
18 to 70 years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
Trial contacts and locations
5
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Data sourced from clinicaltrials.gov
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