A Phase 1/2 interventional study of Celecoxib and Placebo in Breast Cancer, sponsored by Hartford Hospital. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-09.
Sponsored by Hartford Hospital · Phase 1/2, Interventional, and Prevention
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), 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 high risk for breast cancer (gail risk >/= 1.66% for 5 year risk, or personal or family history)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.
Specific Aims:
In women at increased breast cancer risk, determine the effect of vitamin D, with or without celecoxib, on
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.
Proliferative activity in the breast, as measured by Mammary Ductoscopy (MD) cell morphology
Rationale: Both MD and Nipple Aspirate Fluid (NAF) contain ductal epithelial cells, but MD samples contain more cells for cytologic review than NAF. Findings on MD cytology correlate with likelihood of breast cancer (2), NAF cytology relates to breast cancer risk and improves risk stratification (3), and bioactive food components can alter NAF cytology (4).
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 45 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Hartford Hospital is the lead sponsor of 101 studies on the registry; 19 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In this arm, the placebo is in place of celecoxib and the current RDA for cholecalciferol is used the control of the cholecalciferol higher dose.
Drug: Placebo · Drug: Cholecalciferol
Drug: Placebo · Drug: Cholecalciferol
Drug: Celecoxib · Drug: Cholecalciferol
Take one tablet from each bottle (one bottle containing either placebo/celecoxib and one bottle containing either cholecalciferol 400 IU or 2,000 IU) daily for 30 days.
Also known as: celecoxib (Celebrex)
Take one tablet from each bottle (one bottle containing either placebo/celecoxib and one bottle containing either cholecalciferol 400 IU or 2,000 IU) daily for 30 days.
Also known as: placebo (empty capsule inside an empty capsule)
Take one tablet from each bottle (one bottle containing either placebo/celecoxib and one bottle containing either cholecalciferol 400 IU or 2,000 IU) daily for 30 days.
Also known as: cholecalciferol (Vitamin D)
PG synthesis and metabolism
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.
Time frame: approximately 30 days
Proliferative activity in the breast, as measured by MD cell morphology
This will be measured from both baseline and completion samples. 2. Proliferative activity in the breast, as measured by MD cell morphology Rationale: Both MD and NAF contain ductal epithelial cells, but MD samples contain more cells for cytologic review than NAF. Findings on MD cytology correlate with likelihood of breast cancer, NAF cytology relates to breast cancer risk and improves risk stratification, and bioactive food components can alter NAF cytology.
Time frame: approximately 30 days
Circulating levels of 25(OH)D, 1,25(OH)2D, and celecoxib
This will be measured from both baseline and completion samples. 3. Circulating levels of 25(OH)D, 1,25(OH)2D, and celecoxib, and determine if the levels of these compounds correlate with response to markers of PG synthesis and metabolism or cell proliferation.
Time frame: approximately 30 days
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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