An EORTC Randomized, Double Blind, Placebo-Controlled, Phase II Multi-Center Trial Of Anastrozole (Arimidex) In Combination With ZD 1839 (Iressa) Or Placebo In Patients With Advanced Breast Cancer
- Compare the 1 year antitumor activity of anastrozole with vs without gefitinib, in
terms of progression-free survival, in postmenopausal women with metastatic or locally
recurrent advanced breast cancer.
- Compare the objective tumor response and duration of tumor response in patients treated
with these regimens.
- Compare the progression-free survival of patients treated with these regimens.
- Compare the safety of these regimens in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to participating center, dominant site of metastatic disease (bone
alone vs other), prior chemotherapy (no vs yes), stage (metastatic vs locally recurrent),
and measurability (measurable vs evaluable). Patients are randomized to 1 of 2 treatment
- Arm I: Patients receive oral anastrozole and oral gefitinib once daily.
- Arm II: Patients receive oral anastrozole and an oral placebo once daily. In both arms,
treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 8 weeks until disease progression.
PROJECTED ACCRUAL: A total of 108 patients (54 per treatment arm) will be accrued for this
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Progression-free survival at 1 year
at 1 year
Martine J. Piccart, MD, PhD
Institut Jules Bordet
United States: Federal Government