drugset / Trial / NCT01425476
Changes in Breast Cancer Biomarkers Using Synergistic Prostaglandin Inhibitors
Phase 1/2
Completed
45 enrolled
Hartford Hospital
United States Department of Defense · collabUniversity of North Dakota · collab
RandomizedParallel-groupDouble-blindPrevention
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.
Timeline
- Start
- 2008-07
- Primary completion
- 2016-11
- Completion
- 2016-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Celecoxib | Other / unclassified | 400 mg | — |
| Subject | Cholecalciferol | Other / unclassified | 400 iu | — |
| Subject | Cholecalciferol | Other / unclassified | 2000 iu | — |