Modulation of Breast Cancer Risk Biomarkers by High Dose Vitamin D
Protocol Objectives:
To determine if high dose vitamin D3 given to premenopausal women who initially have
insufficient levels of 25-hydroxy vitamin D (<30 ng/ml) will raise 25(OH)D levels above the
50 ng/ml level considered to be required for breast health. If so, will certain risk
biomarkers for development of breast cancer be reliably and favorably modulated? The
primary endpoint will be a decrease in mammographic breast density (percent area considered
at increased density). Change in proliferation (a decrease as assessed by Ki-67) will also
be examined. Modulate of expression of genes important in breast cancer risk or reflective
of vitamin D's mechanism of action will be studied using quantitative real time polymerase
chain reaction (qRT-PCR).
Study Design:
The study is a single-arm open label clinical trial. Women who are high risk for
development of breast cancer on the basis of family or personal history will undergo random
periareolar fine needle aspiration (RPFNA) to acquire breast cells for assessment of gene
expression by qRT-PCR. Women with mammographic density >10% will be eligible for
enrollment. All subjects will receive high dose vitamin D3 (3 capsules of 10,000 IU of
vitamin D3 every week for 6-8 months). At that time, a repeat RPFNA and mammogram will be
performed. Measurement of serum levels of 25(OH)D will be performed at baseline, 3 months,
and 6 months.
Interventional
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Mammographic breast density
Assessed as area of mammogram at increased density
baseline and 6 months
No
Carol Fabian, MD
Principal Investigator
University of Kansas
United States: Food and Drug Administration
11657
NCT01166763
May 2009
June 2011
Name | Location |
---|---|
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |