Changes in Breast Cancer Biomarkers Using Synergistic 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), 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
• Collaborators: United States Department of Defense; University of North Dakota
• Treatments: Celecoxib; Cholecalciferol; Ergocalciferols; Prostaglandin Antagonists; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Women 18 years of age or older

• Increased risk for breast cancer (demonstrated by strong family history [one 1st degree or two 2nd degree relatives], history of DCIS, IBC, or precancerous changes in breasts). OR Gail Model risk of developing IBC in a 5-year period of >1.66%

• Women with a history of breast cancer, must be free of disease and finished with treatment

• 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 candidate

• 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