Pilot Biomarker Modulation Study of Vitamin D in Premenopausal Women at High Risk for Breast Cancer
The investigators 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.
Interventional
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Safety and Feasibility
2 years
Yes
Katherine Crew, MD
Principal Investigator
Columbia University
United States: Food and Drug Administration
AAAC3089
NCT00976339
September 2007
July 2013
Name | Location |
---|---|
Columbia University Medical Center Herbert Irving Cancer Center | New York, New York 10032 |