Changes in Breast Cancer Biomarkers Using Synergistic Prostaglandin Inhibitors

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT01425476

Run by

Hartford Hospital

People needed

45

Starts

2008-07-01

Expected to finish

2016-11-01

Last updated by the study team

2017-08-09

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of North Dakota — Grand Forks, North Dakota, United States

Full record on ClinicalTrials.gov

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