To assess the effects of twelve months of celecoxib administration by evaluating breast tissue needle aspirations, to determine if cell growth can be slowed.
A blind randomized study of celecoxib in women at high risk of developing breast cancer. Subjects are to take twelve months of drug/placebo. At baseline and after twelve months subjects will have a random periareolar fine needle breast aspiration that will be assessed for epithelial cell growth and other markers of risk. Baseline and twelve month serum samples will also be assessed for hormones and growth factors which may be associated with breast cancer risk. Mammograms at baseline and twelve months will also be assessed for breast density changes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
72
University of Kansas Medical Center
Kansas City, Kansas, United States
Change in Percent of Breast Epithelial Cells Staining Positive for Ki-67
Immunocytochemical staining of breast epithelial cells. Positive cells reflect proliferative activity.
Time frame: Baseline and 12 months
Mammographic Breast Density
The percent of mammographic breast area that is considered to be at increased density. Evaluated using the semi-automated computer program Cumulus.
Time frame: Baseline and 12 months
Serum Estradiol Concentration
Change in serum estradiol concentration
Time frame: Baseline to 12 months
Serum Sex Hormone Binding Globulin (SHBG) Concentration
Change in serum concentration
Time frame: Baseline to 12 months
Molecular Ratio of Serum Concentration of IGF-1 to IGFBP3
Change ion ratio.
Time frame: baseline to 12 months
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