Breast Cancer Risk Biomarkers in Premenopausal 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 premenopausal 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 an Intervention of Lovaza™ 4 Grams Per Day	6 month visit	The proportion of subjects that complete an intervention of Lovaza™ 4 grams per day (\~ 1800 mg EPA and 1500 mg DHA) administered for 6 months to premenopausal women under age 55.

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.
Modulation of Ki-67 Expression	6 month value compared to baseline value	Change (baseline to end of study) in percent of benign breast epithelial cells exhibiting immunostaining for Ki-67
Change in (DHA+EPA):AA Ratio for Phospholipids in Plasma.	baseline to end of intervention (~6 months)	Change (from baseline to end of study) for the ratio derived from levels of DHA, EPA, and Arachadonic Acid (AA); measured as percent of total fatty acid content in the phospholipid compartment of plasma.
Change in Quality of Life.	duration of intervention, baseline to ~ 6 months	Change in score on Breast Cancer Prevention Trial (BCPT) Symptom Checklist. 43 symptoms, each scored as 0 to 4, are summed to provide a global score (range 0 to 172). Increasing score represents increasing problems with side effects. For change in score over period of intervention, a negative score indicates an improvement in quality of life while a positive score indicates increasing interference with daily activities due to worsening symptoms. Theoretically, the range of change could be -172 to +172.