Changes in Breast Cancer Biomarkers Using Synergistic Prostaglandin Inhibitors

NCT01425476 | Completed Phase 1

• 1 other identifier: 200806
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

breast; high risk women; biomarkers; vitamin D

Outcome Measures

Primary Outcomes (1)

• PG synthesis and metabolism

  This will be measured from both baseline and completion samples. 1\. PG synthesis and metabolism, through the measurement of 15-PGDH, COX-2, and PGE2 in the breast Rationale: 1,25(OH)2D, the active form of vitamin D, has been shown in vitro to decrease PGE2 both by interfering with its production and by increasing its breakdown, leading to lower cell proliferation. Celecoxib potentiated the antiproliferative effect, allowing a much lower dose of each agent when used in combination than in isolation.

  approximately 30 days

Secondary Outcomes (2)

• Proliferative activity in the breast, as measured by MD cell morphology

  approximately 30 days

• Circulating levels of 25(OH)D, 1,25(OH)2D, and celecoxib

  approximately 30 days

Study Arms (3)

Placebo & cholecalciferol 400 IU

PLACEBO COMPARATOR

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.

Drug: Placebo; Drug: Cholecalciferol

Placebo & cholecalciferol 2,000 IU

ACTIVE COMPARATOR

Drug: Placebo; Drug: Cholecalciferol

celecoxib 400 mg & cholecalciferol 2,000 IU

EXPERIMENTAL

Drug: Celecoxib; Drug: Cholecalciferol

Interventions

Celecoxib DRUG

Take one tablet from each bottle (one bottle containing either placebo/celecoxib and one bottle containing either cholecalciferol 400 IU or 2,000 IU) daily for 30 days.

Also known as: celecoxib (Celebrex)

celecoxib 400 mg & cholecalciferol 2,000 IU

Placebo DRUG

Take one tablet from each bottle (one bottle containing either placebo/celecoxib and one bottle containing either cholecalciferol 400 IU or 2,000 IU) daily for 30 days.

Also known as: placebo (empty capsule inside an empty capsule)

Placebo & cholecalciferol 2,000 IU; Placebo & cholecalciferol 400 IU

Cholecalciferol DRUG

Take one tablet from each bottle (one bottle containing either placebo/celecoxib and one bottle containing either cholecalciferol 400 IU or 2,000 IU) daily for 30 days.

Also known as: cholecalciferol (Vitamin D)

Placebo & cholecalciferol 2,000 IU; Placebo & cholecalciferol 400 IU; celecoxib 400 mg & cholecalciferol 2,000 IU

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Hartford Hospital: lead
• United States Department of Defense: collaborator
• University of North Dakota: collaborator

Study Sites (1)

University of North Dakota

Grand Forks, North Dakota, 58203, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Celecoxib; Cholecalciferol; Vitamin D

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Edward Sauter, MD, PhD

  University of North Dakota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, M.H.A

Study Record Dates

• First Submitted: April 26, 2011
• First Posted: August 30, 2011
• Study Start: July 1, 2008
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: August 9, 2017

Record last verified: 2017-08

Locations

US (1)