Breast Cancer Risk Biomarkers in Postmenopausal Women
This study has been completed.
Information provided by (Responsible Party):
Carol Fabian, MD, University of Kansas Medical Center Research Institute
First received: November 23, 2010
Last updated: December 17, 2013
Last verified: December 2013
This study is designed to gather information on how the prescription drug Lovaza™ which contains omega-3 fatty acids, affects blood and tissue risk biomarkers for breast cancer. This drug is currently approved by the FDA for reducing blood levels of triglycerides.
||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
||Modulation of Breast Cancer Risk Biomarkers in Postmenopausal Women by High Dose Omega-3 Fatty Acids
Primary Outcome Measures:
Secondary Outcome Measures:
- To assess the potential efficacy [ Time Frame: 6 month visit ] [ Designated as safety issue: No ]
To assess the potential efficacy as demonstrated by significant modulation of 1 or more risk biomarkers
- To assess change in cell fatty acid signatures with Lovaza™ [ Time Frame: 6 month visit ] [ Designated as safety issue: No ]
To assess change in cell fatty acid signatures with Lovaza™ especially change in erythrocyte and breast tissue phospholipid EPA and DHA or the combination relative to Arachidonic Acid (AA) and correlate these changes with those in risk biomarkers, and mechanism of action biomarkers, and total oral intake.
- To measure change in quality of life with Lovaza™ [ Time Frame: 6 month visit ] [ Designated as safety issue: No ]
To measure change in quality of life with Lovaza™ and correlate with change if any with change in erythrocyte phospholipid fatty acid signatures particularly EPA:AA, DHA:AA, EPA +DHA:AA
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2013 (Final data collection date for primary outcome measure)
4 capsules daily for 6 months
|Ages Eligible for Study:
||25 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Women that have had a metastatic malignancy of any kind.
- Women that have had prior invasive breast cancer, diagnosed or treated within the past five years.
- Women who are currently taking anticoagulants.
- Women who have breast implants.
- Women who have undergone change in their hormonal milieu in the past 6 months.
- Women who have taken omega 3 fatty acid or flaxseed supplements within 3 weeks prior to their baseline RPFNA or women who have taken high dose omega 3 within the past three months.
- Women who regularly take NSAIDS (>7 tablets weekly).
- Women who have taken a SERM, aromatase inhibitor or participated in a chemoprevention or other investigational drug study within six months prior to baseline FNA.
- Women who have abnormal renal or hepatic function at baseline, defined as blood chemistry values clinically significantly outside of normal institutional ranges.
- Women who have a history of an allergy, including hives, to fish products.
- Women who have a BMI of 40 Kg/m2 or greater.
Inclusion of Women and Minorities This study utilizes women at increased risk for breast cancer. Subjects recruited from an established cohort of women followed in the Breast Cancer Prevention Center. From previous trials we can expect 6% minority accrual which is similar to our hospital demographics. Males are not included due to the low absolute risk of breast cancer, and the difficulty of performing RPFNA on the male breast.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01252290
|University of Kansas Medical Center
|Kansas City, Kansas, United States, 66160 |
Carol Fabian, MD
||Carol Fabian, MD
||University of Kansas
No publications provided
ClinicalTrials.gov processed this record on March 25, 2015
||Carol Fabian, MD, Professor, Director Breast Cancer Prevention Unit, University of Kansas Medical Center Research Institute
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 23, 2010
||December 17, 2013
||United States: Human Subjects Committee