Changes in Biomarkers Using Prostaglandin Inhibitors

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hartford Hospital
• Collaborator: Susan G. Komen Breast Cancer Foundation
• Treatments: Celecoxib; Cholecalciferol; Vitamin D; Vitamins

Criteria

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