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Prostaglandin Inhibition to Prevent Breast Cancer


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Female
Biomarker Change Linked to Breast Cancer

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Trial Information

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
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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

PG synthesis and metabolism, through the measurement of PGE2, COX-2 and 15-PGDH in the breast

Outcome Description:

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.

Outcome Time Frame:

approximately 30 days

Safety Issue:

No

Principal Investigator

Edward R. Sauter, MD, PhD, M.H.A

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Dakota

Authority:

United States: Institutional Review Board

Study ID:

200807-001

NCT ID:

NCT01769625

Start Date:

January 2009

Completion Date:

Related Keywords:

  • Biomarker Change Linked to Breast Cancer
  • breast
  • high risk women
  • biomarkers
  • vitamin D
  • Breast Neoplasms

Name

Location

University of North DakotaGrand Forks, North Dakota  58203