Prostaglandin Inhibition to Prevent Breast Cancer
This is a biomarker study with the goal of measuring changes in protein and rna expression.
This study is not intended for use in diagnosing, mitigating, treating, curing, or
66 women at normal risk for developing breast cancer will be recruited and enrolled. 22
women will be randomized into each arm, with anticipation of 2 women in each group will not
be evaluable, leaving 20 in each group for evaluation.
A combination of vitamin D and celecoxib act synergistically to decrease breast cancer risk
by decreasing cell proliferation in the mammary epithelium through their action on
prostaglandin synthesis and metabolism.
-Evaluate vitamin D metabolism, through the measurement of CYP24 in the breast.
2-Evaluate breast specific levels of vitamin D and celecoxib, and assess if the levels of
these compounds correlate with response to markers which influence prostaglandin synthesis
and metabolism. Additionally, in women without active breast cancer , we will determine the
effect of vitamin D, with or without celecoxib, on 1) PG synthesis and metabolism, through
the measurement of PGE2, COX-2 and 15-PGDH in the breast, 2) proliferative activity in the
breast,, and 3) circulating levels of vitamin D and celecoxib, to determine if levels of
these compounds correlate with response to markers of PG production, metabolism, or cell
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
PG synthesis and metabolism, through the measurement of PGE2, COX-2 and 15-PGDH in the breast
This will be measured from both baseline and completion samples 1. PG synthesis and metabolism, through the measurement of 15-PGDH, COX-2, and PGE2 in the breast Rationale: 1,25(OH)2D, the active form of vitamin D, has been shown in vitro to decrease PGE2 both by interfering with its production and by increasing its breakdown, leading to lower cell proliferation. Celecoxib potentiated the antiproliferative effect, allowing a much lower dose of each agent when used in combination than in isolation.
approximately 30 days
Edward R. Sauter, MD, PhD, M.H.A
University of North Dakota
United States: Institutional Review Board
|University of North Dakota||Grand Forks, North Dakota 58203|