Status:
COMPLETED
Changes in Breast Cancer Biomarkers Using Synergistic Prostaglandin Inhibitors
Lead Sponsor:
Hartford Hospital
Collaborating Sponsors:
United States Department of Defense
University of North Dakota
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
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. T...
Detailed Description
This is a biomarker study with the goal of measuring changes in protein and RNA expression. This study is not intended for use in diagnosing, mitigating, treating, curing, or preventing disease. 66 w...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01425476
Start Date
July 1 2008
End Date
November 1 2016
Last Update
August 9 2017
Active Locations (1)
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1
University of North Dakota
Grand Forks, North Dakota, United States, 58203