Clinical trial · Interventional
Changes in Biomarkers Using Prostaglandin Inhibitors
Prostaglandin Inhibition to Prevent Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biomarker Change Linked to Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo/celecoxib 400 mg and cholecalciferol 400 IU/cholecalciferol 2,000 IU | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- placebo & cholecalciferol 400 IU
- description
- In this arm, the placebo is in place of celecoxib and the current RDA for cholecalciferol is used the control of the cholecalciferol higher dose.
- interventionNames
- Drug: placebo/celecoxib 400 mg and cholecalciferol 400 IU/cholecalciferol 2,000 IU
- type
- ACTIVE_COMPARATOR
- label
- placebo & cholecalciferol 2,000 IU
- description
- Placebo \& cholecalciferol 2,000 IU
- interventionNames
- Drug: placebo/celecoxib 400 mg and cholecalciferol 400 IU/cholecalciferol 2,000 IU
- type
- EXPERIMENTAL
- label
- celecoxib 400mg & cholecalciferol 2,000 IU
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available