Overview

This trial is active, not recruiting.

Condition biomarker change linked to breast cancer
Treatment placebo/celecoxib 400 mg and cholecalciferol 400 iu/cholecalciferol 2,000 iu
Phase phase 1/phase 2
Sponsor The University of Texas Health Science Center at Tyler
Collaborator Susan G. Komen Breast Cancer Foundation
Start date January 2009
End date November 2016
Trial size 31 participants
Trial identifier NCT01769625, 200807-001

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacodynamics study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Placebo Comparator)
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.
placebo/celecoxib 400 mg and cholecalciferol 400 iu/cholecalciferol 2,000 iu celecoxib (Celebrex)
Take 1 capsule from each bottle (1 bottle containing either placebo/celecoxib and 1 bottle containing either cholecaliferol 400 IU/cholecaliferol 2,000 IU) for 30 days
(Active Comparator)
Placebo & cholecalciferol 2,000 IU
placebo/celecoxib 400 mg and cholecalciferol 400 iu/cholecalciferol 2,000 iu celecoxib (Celebrex)
Take 1 capsule from each bottle (1 bottle containing either placebo/celecoxib and 1 bottle containing either cholecaliferol 400 IU/cholecaliferol 2,000 IU) for 30 days
(Experimental)
celecoxib 400 mg & cholecalciferol2,000 IU
placebo/celecoxib 400 mg and cholecalciferol 400 iu/cholecalciferol 2,000 iu celecoxib (Celebrex)
Take 1 capsule from each bottle (1 bottle containing either placebo/celecoxib and 1 bottle containing either cholecaliferol 400 IU/cholecaliferol 2,000 IU) for 30 days

Primary Outcomes

Measure
PG synthesis and metabolism, through the measurement of PGE2, COX-2 and 15-PGDH in the breast
time frame: approximately 30 days

Secondary Outcomes

Measure
proliferative activity in the breast and 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.
time frame: approximately 30 days

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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

Additional Information

Official title Prostaglandin Inhibition to Prevent Breast Cancer
Principal investigator Edward R. Sauter, MD, PhD, M.H.A
Description 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. Specific Aims: -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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by The University of Texas Health Science Center at Tyler.