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Despite significant advances in the early detection and treatment of breast cancer, it is still the most common cancer among women in the U.S. and up to 25% will die of their disease. Therefore, more attention has focused on primary prevention to reduce breast cancer-related morbidity and mortality. Due to the limited number of significant modifiable risk factors for breast cancer, researchers are exploring the potential of chemoprevention to arrest or reverse cancer development with a drug intervention. Currently, tamoxifen is the only FDA-approved drug for breast cancer risk reduction. However, tamoxifen's adverse effects have limited its usage. It is anticipated that raloxifene will be used more, as it has a more favorable side effect profile. However, tamoxifen and raloxifene do not prevent estrogen receptor (ER)-negative breast tumors, which account for about a third of all breast cancers and are associated with a poorer prognosis. Current priorities in breast cancer chemoprevention are to identify preventive agents which may be effective against ER-negative breast cancers, and have a low risk of side-effects.
Vitamin D is a fat-soluble vitamin which is produced in the body and may come from food sources. Epidemiologic studies suggest that vitamin D may influence breast cancer development, which has resulted in increased interest in the use of vitamin D for the treatment and prevention of breast cancer. Numerous experimental studies have shown that vitamin D compounds have anti-carcinogenic properties against breast cancer. Given the epidemiologic data and the extensive preclinical evidence of the anti-tumor effects of vitamin D, it is therefore reasonable to test the biological effects of high-dose vitamin D in early phase clinical trials. The investigators hypothesize that vitamin D3, cholecalciferol, will modulate biomarkers of breast cancer risk.
We plan to conduct a pilot feasibility study in 20 premenopausal women who are at high risk for breast cancer development who will receive oral cholecalciferol (vitamin D3) 30,000 IU (n = 10) or 20,000 IU (n = 10) weekly for one year. Pretreatment and posttreatment mammograms, breast biopsies, and blood will be evaluated for a variety of biomarkers. The primary objective of this study is to determine the feasibility and toxicity associated with this 1-year intervention of vitamin D in this study population. The secondary objective is to obtain preliminary data on the biological effects of vitamin D on normal breast tissue. The results of this pilot study will be used to implement a larger multicenter trial of vitamin D for breast cancer chemoprevention.
Allocation: Non-Randomized, Control: Active Control, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
cholecalciferol (Vitamin D3), cholecalciferol (Vitamin D3)
Columbia University Medical Center Herbert Irving Cancer Center
Published on BioPortfolio: 2014-08-27T03:19:23-0400
This is a phase II study which will enroll 40 postmenopausal women who are at high risk for breast cancer development. The goal is to determine whether a one-year intervention of high-dose...
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A cytochrome P-450 enzyme that has specificity for CHOLECALCIFEROL (Vitamin D3). It hydroxylates the molecule at carbon position 24.
Hydroxy analogs of vitamin D 3; (CHOLECALCIFEROL); including CALCIFEDIOL; CALCITRIOL; and 24,25-DIHYDROXYVITAMIN D 3.
A lipid cofactor that is required for normal blood clotting. Several forms of vitamin K have been identified: VITAMIN K 1 (phytomenadione) derived from plants, VITAMIN K 2 (menaquinone) from bacteria, and synthetic naphthoquinone provitamins, VITAMIN K 3 (menadione). Vitamin K 3 provitamins, after being alkylated in vivo, exhibit the antifibrinolytic activity of vitamin K. Green leafy vegetables, liver, cheese, butter, and egg yolk are good sources of vitamin K.
A nutritional condition produced by a deficiency of VITAMIN D in the diet, insufficient production of vitamin D in the skin, inadequate absorption of vitamin D from the diet, or abnormal conversion of vitamin D to its bioactive metabolites. It is manifested clinically as RICKETS in children and OSTEOMALACIA in adults. (From Cecil Textbook of Medicine, 19th ed, p1406)
OXIDOREDUCTASES which mediate vitamin K metabolism by converting inactive vitamin K 2,3-epoxide to active vitamin K.
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