Breast Cancer Clinical Trial
Changes in Biomarkers Using Prostaglandin Inhibitors
This is a biomarker study with the goal of measuring changes in proteins and gene methylation. This study is not intended for use in diagnosing, mitigating, treating, curing, or preventing disease.
The purpose of this study is to determine if Vitamin D (cholecalciferol) alone and in combination with celecoxib (Celebrex, a non-steroidal anti-inflammatory drug, or NSAID), act together to decrease breast cancer risk by their effect on certain biological indicators (biomarkers) of breast cancer risk (called PGE2, COX-2, and 15-PGDH) and cell changes in the breast.
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 preventing disease.
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 proliferation.
Woman >18 years old
Healthy women who are at normal risk for developing breast cancer
ECOG Performance Status score 0-1
Premenopausal women must not be pregnant
History of bilateral mastectomy, or bilateral breast irradiation
Significant medical or psychiatric problems making the participant a poor candiate
Evidence of excess use of narcotics or drug dependency
Have been pregnant and lactating in the past 2 years
Significant history of peptic ulcer disease or upper gastrointestinal bleeding
History of severe congestive heart failure that requires hospitalization or intervention
History of asthma requiring medication for treatment
Allergy to sulfonamides or NSAID medications
History of myocardial infarction or stroke
Currently on Coumadin
Currently on Tamoxifen (nolvadex),Evista (raloxifene), Femara (letrozole), Arimidex (anastrozole), or Aromasin (exemestane)
Undergone prior subaeolar breast surgery
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There is 1 Location for this study
Grand Forks North Dakota, 58202, United States
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