LY353381 in Preventing Breast Cancer in Women With Hyperplasia
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of LY353381 may be an effective way to prevent the development of breast cancer in women who have hyperplasia.
PURPOSE: Randomized phase II trial to study the effectiveness of LY353381 in preventing breast cancer in women who have hyperplasia.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Prevention
|Official Title:||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|
- Change in Masood Score [ Time Frame: Baseline to 6 months ]
Change in the semi-quantitative score assigned by the designated cytopathologist.
Range 6-24. Score represents increasing abnormality (i.e., worse appearance) Sum composite of 6 cytomorphological features, each scored as 1-4.
- Number of Participants With Improvement From Baseline in Cytomorphologic Abnormality at 6 Months [ Time Frame: Baseline to 6 months ]
Change (improvement) in categorical descriptor of cytologic abnormality as assigned by the primary cytopathologist.
Categories include: normal (non-proliferative), epithelial hyperplasia, epithelial hyperplasia with atypia.
|Study Start Date:||August 2000|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
matched tablet dialy
LY353381, 20 mg daily
one tablet daily
Other Name: LY353381
- 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 effect biomarkers.
- 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 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005879
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160-7820|
|United States, Texas|
|U.S. Oncology Research, Inc.|
|Dallas, Texas, United States, 75246|
|Study Chair:||Carol J. Fabian, MD||University of Kansas|