Breast Cancer Risk Biomarkers in Postmenopausal Women

Phase 2

Completed

Brief Summary: 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.

Detailed Description: The central hypothesis is that 6 months of administration of high dose omega-3 fatty acid esters \[eicosapentaenoic acid (EPA) 1860 mg, and docosahexaenoic acid (DHA) 1500 mg\] daily in the form of a standard prescription strength dose of Lovaza™ (two 1 gram capsules twice daily) will have a favorable side effect profile and potential efficacy as demonstrated by favorable modulation of one or more blood and breast tissue risk biomarkers for breast cancer in postmenopausal women.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Lovaza™	Lovaza™	Lovaza™ (two 1 gram capsules twice daily) for six months

Primary Outcome Measures

Name	Time	Method
The Proportion of Subjects That Complete Intervention of Lovaza™ 4 Grams Per Day	6 month visit	To determine the feasibility of an intervention of Lovaza™ 4 grams per day (\~ 1800 mg EPA and 1500 mg DHA) administered for 6 months to post-menopausal women under the age of 50.

Secondary Outcome Measures

Name	Time	Method
Modulation of the Risk Biomarker Masood Score	6 month value compared to baseline value	Change in the semiquantitative cytology index score (Masood score) from baseline to end of study. Masood Score range 6 - 24; increasing values denote increasing cytologic abnormality. Thus, negative values for change reflect an improvement, i.e., less cytologic abnormality after intervention.
Change in Quality of Life	Change from Baseline to Month 6	Change in score on Breast Cancer Prevention Trial (BCPT) Symptom Checklist. Summation score of degree of difficulty (scored 0 to 4 each) with 43 individual activities. Thus total score ranges from 0 to 172. Increasing score represents increasing problems with side effects.
Change in (DHA+EPA):AA Ratio for Phospholipids in Plasma	Change from Baseline to Month 6	Change (from baseline to end of study) for the ratio derived from levels of DHA, EPA, and AA (measured as percent of total fatty acid content) in the phospholipid compartment of plasma.
Change in Ki-67 Expression	6 month value compared to baseline value	Immunocytochemical staining for Ki-67 antibody. Percent of 500 benign breast epithelial cells scored that are classified as positively staining.