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
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
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using ICI 182780 before surgery may block the uptake of estrogen by the tumor cells and prevent metastases. It is not yet known if ICI 182780 is effective in preventing breast cancer metastases.
PURPOSE: Randomized phase III trial to study the effectiveness of ICI 182780 given before surgery in treating women who have stage I or stage II primary breast cancer.
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and menopausal status (premenopausal vs postmenopausal).
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 annually thereafter.
PROJECTED ACCRUAL: A total of 3,656 patients (1,828 per arm) will be accrued for this study within 2 years.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed stage I or II primary operable breast cancer
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other: