A Phase II Clinical Trial of a Selective Estrogen Receptor Modulator (LY353381*HCl) in High Risk Women With Fine Needle Aspiration Cytologic Evidence of Hyperplasia
- Determine if LY353381 hydrochloride improves baseline cytology in women at high risk
for breast cancer.
- Determine if this drug modulates other potential surrogate endpoint biomarkers or drug
- Determine if cytologic improvement is associated with initial presentation of the
various stratification factors.
- Determine whether cytology is correlated with other potential surrogate endpoint
biomarkers or drug effect biomarkers and whether change in cytology is correlated with
change in the other biomarkers.
- Monitor the effects of this drug in terms of quality of life and women's health.
OUTLINE: This is a randomized, double-blind, multicenter study followed by an open-label
study for both arms. Patients are stratified according to cytologic status (hyperplasia with
atypia vs hyperplasia without atypia), mutation status (known carrier for BRCA1 or BRCA2
genes vs known not to be a carrier of mutant genes), menopausal status (premenopausal vs
postmenopausal), estrogen-receptor status, and participating center. Patients are randomized
to one of two treatment arms.
- Arm I: Patients receive oral LY353381 hydrochloride once daily for 6 months.
- Arm II: Patients receive oral placebo once daily for 6 months. Patients in both arms
then receive oral LY353381 hydrochloride for an additional 6 months.
Quality of life is assessed at baseline and then at 6 and 12 months.
Patients are followed at 2 weeks and then annually for 5 years.
PROJECTED ACCRUAL: A total of 210-220 patients will be accrued for this study within 2.5-3
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
Carol J. Fabian, MD
University of Kansas
United States: Federal Government
|University of Kansas Medical Center
|Kansas City, Kansas 66160-7353
|U.S. Oncology Research, Inc.
|Dallas, Texas 75246