Protocol for Women at Increased Risk of Developing Breast Cancer
A pilot study to assess the effects of six months of letrozole on breast tissue risk markers in postmenopausal women on hormone replacement therapy at high risk of developing breast cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Study of the Effect of Letrozole on Breast Biomarkers of High Risk Postmenopausal Women Receiving Hormone Replacement Therapy|
- Change in Proliferation of Breast Epithelial Cells Obtained by Random Periareolar Fine Needle Aspiration. [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]Proliferation assessment by immunocytochemistry using Ki-67. Expressed as percent of cells staining positive for Ki-67.
|Study Start Date:||January 2003|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Letrozole 2.5 mg daily
Other Name: Femara
A pilot study of letrozole in postmenopausal women on hormone replacement therapy at high risk of developing breast cancer. Subjects will have hyperplasia with atypia (or borderline Epithelial Hyperplasia/Atypical Hyperplasia) and evidence of Estrogen Receptor expression by random periareolar fine needle aspiration and baseline serum estradiol levels less than or equal to 150 pg/ml. The feasibility of performing RT-qPCR on breast specimens for aromatase expression will also be done at baseline.
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Carol J Fabian, MD||University of Kansas|