A Double-Blind Phase III Clinical Trial to Compare the Effects of a Pre-Operatively Administered Single Dose of "Faslodex" (Long-Acting ICI 182.780) With Placebo on Tumor Recurrence in Pre- and Postmenopausal Women Treated for Operable First Primary Breast Cancer
- Determine the inhibitory effect of ICI 182780 on the development of metastasis, as
measured by disease-free survival and overall survival, in women with operable stage I
or II primary breast cancer.
- Determine toxicity of this regimen in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to participating center and menopausal status (premenopausal vs
Patients are randomized to receive either ICI 182780 IM or placebo IM over 2 minutes on day
1. Patients undergo surgery between days 8 and 29.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
PROJECTED ACCRUAL: A total of 3,656 patients (1,828 per arm) will be accrued for this study
within 2 years.
Primary Purpose: Treatment
Cornelis J.H. van de Velde, MD, PhD, FRCS, FRCPS
Leiden University Medical Center
United States: Federal Government