Modulation of Breast Cancer Risk Biomarkers by High Dose Vitamin D

Exclusion Criteria

• •Subject must have had a mammogram performed at the University of Kansas Breast Imaging Center with estimated visual breast density of greater than 10 percent.
• •Subject must have had within six months prior to entering the study, an RPFNA during the follicular portion (day 1-10) of the menstrual cycle with material for cytomorphology, Ki-67 and qRT-PCR; in addition to serum obtained and banked.
• •Subjects must have 25(OH)D level \< 30 ng/ml as measured within 8 weeks of starting intervention. Subjects may have been identified as having low vitamin D levels through participation in HSC 11313, Osteopenia/Osteoporosis in Pre-menopausal Women at High Risk for Development of Breast Cancer, but low level must be confirmed within 8 weeks prior to starting study agent Subject must be willing to continue the same hormonal milieu present at baseline throughout trial.
• •Subjects must be willing to undergo measurement of height, weight, and BMI at initiation of intervention.
• •Subjects must have participated in HSC 11313, and have had a DEXA scan for bone density and body fat analysis on the GE Lunar Prodigy Advance research unit in the Breast Cancer Survivorship Center.
• •Subjects must be willing to sign an informed consent for the entire study and separate consent for repeat RPFNA.
• •Women that have had a metastatic malignancy of any kind.
• •Women that have had prior invasive breast cancer If subject has had a DCIS, at least two months must have elapsed from surgery and/or radiation therapy to the involved breast. Only the contra-lateral (uninvolved breast) will be studied by FNA. The subject may not have had any radiation therapy to the contra-lateral breast to be studied.
• •Women who are pregnant or nursing.
• •Women who have taken a SERM, aromatase inhibitor or participated in a chemoprevention or other investigational drug study within six months prior to baseline FNA.
• •Women who have used fertility drugs within six months prior to baseline aspiration.
• •Women with a history of sarcoidosis, hypercalcemia, hyperparathyroidism, or renal stones.
• •Women who are receiving treatment for rheumatoid arthritis or other connective tissue diseases.
• •Women who have an elevated blood calcium level at baseline; defined as any elevation above the institutional normal range.