Biomarker Change Linked to Breast Cancer Clinical Trial
Official title:
Prostaglandin Inhibition to Prevent Breast Cancer
| Verified date | August 2017 |
| Source | Hartford Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 31 |
| Est. completion date | November 2016 |
| Est. primary completion date | November 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of North Dakota | Grand Forks | North Dakota |
| Lead Sponsor | Collaborator |
|---|---|
| Hartford Hospital | Susan G. Komen Breast Cancer Foundation |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | 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. | 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 |
approximately 30 days |