Study of Breast Cancer Prevention by Letrozole in High Risk Women
This is a multi-institution double-blind placebo-controlled trial whose main objective is to determine if 6 months of letrozole (2.5 mg daily) can reduce proliferation as assessed by Ki-67 in high risk postmenopausal women on systemic hormone replacement therapy who have random periareolar fine needle aspiration (RPFNA) evidence of hyperplasia with atypia or borderline atypia, and a minimum Ki-67 of >1.5%.
The primary hypothesis is that proliferation and expression of other estrogen response genes will be favorably modulated by six months of letrozole relative to placebo without substantially increasing hot flashes or worsening overall quality of life.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||Study of Breast Cancer Prevention by Letrozole in High Risk Women|
- Change in Proliferation Rate (Ki-67 by Immunocytochemistry) From Baseline to 6 Months [ Time Frame: Baseline to 6 Months ]Change in proliferation rate (percent positively stained cells for Ki-67 antigen by immunocytochemistry) in benign breast epithelial cells acquired by random periareolar fine needle aspiration from women at high risk for the development of breast cancer.
- Assessment of Change in Morphology by the Masood Score. [ Time Frame: Baseline to 6 Months ]Masood score is a semi-quantitative index of increasing abnormality, thus higher values are worse. Range 6 to 24.
- Change in Mammographic Density From Baseline to 6 Months.. [ Time Frame: Baseline to 6 Months ]Percent area of the breast considered to be at increased density, as determined by the computer program Cumulus..
- Change in Biomarkers Associated With Bone and Cardiovascular Health, Adverse Events, Breast Cancer Prevention Trial (BCPT) Symptom Check List, Hot Flash Score, General Fatigue Inventory, the Fibromyalgia Impact Questionnaire. [ Time Frame: 6 Months, 12 Months ]
|Study Start Date:||October 2006|
|Study Completion Date:||March 2015|
|Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Letrozole, 2.5 mg daily for 6 months
Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months.
Other Name: Letrozole(Femara)
Placebo Comparator: Placebo
Placebo, daily for 6 months
Placebo tablet daily for 6 months then optional open label letrozole for 6 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00579826
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Carol J Fabian, MD||University of Kansas Medical Center|