Changes in Biomarkers Using Prostaglandin Inhibitors

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

Conditions studied: Biomarker Change Linked to 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), 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.

Key facts

Study ID

NCT01769625

Run by

Hartford Hospital

People needed

31

Starts

2009-01-01

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…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.