Phase IIb Trial of G-2535 (Unconjugated Isoflavones-100) in Women at High Risk for Breast Cancer
- Determine the effect of genistein on the proliferation of breast epithelial cells
obtained by fine needle aspiration (FNA), as measured by Ki-67 labeling index, in women
who are at high risk for breast cancer.
- Determine the effect of this drug on cellular and molecular parameters using epithelial
cells obtained by FNA, nipple aspirate fluid, and blood from these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
stratified according to menopausal status (premenopausal vs postmenopausal) and history of
breast cancer (no history of breast cancer vs history of estrogen receptor [ER] positive
breast cancer vs history of ER negative breast cancer). Patients are randomized to 1 of 2
- Arm I: Patients receive oral genistein once daily.
- Arm II: Patients receive oral placebo once daily. In both arms, treatment continues for
up to 6 months in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed at 30-37 days.
PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Determine effect upon proliferation of breast epithelial cells obtained by fine needle aspiration (FNA)
Determine intervention related effect upon proliferation of breast epithelial cells, obtained by fine needle aspiration (FNA), as measured by Ki-67 labeling index at screening and at six months.
At screening and at six months
Seema A. Khan, MD
Robert H. Lurie Cancer Center
United States: Food and Drug Administration
|Northwestern University||Chicago, Illinois 60611|
|Lynn Sage Comprehensive Breast Center at Northwestern Memorial Hospital||Chicago, Illinois 60611|