Breast Cancer Risk Biomarkers in Premenopausal Women

Exclusion Criteria

• •Subjects \> 40 must have had a screening mammogram within 6 months of entering the interventional portion of the study and read as not suspicious for breast cancer or if suspicious must have completed all suggested tests including biopsy and found to have no evidence of cancer. Subjects of sufficient age and/or risk for a baseline mammogram must be willing to have an off-study mammogram performed 6 months after study entry.
• •Subjects must have had an RPFNA of the breast within six months prior to entering the intervention portion of the study and be willing to have another RPFNA at \~6.5 months after starting Lovaza™.
• •Tissue Eligibility: Subjects must have cytomorphologic evidence of hyperplasia with atypia or borderline atypia (Masood score 14 or higher). There must be ≥500 epithelial cells on the slide for cytomorphology and evidence of proliferation by Ki-67 staining. There must be sufficient reserved methanol- formalin-fixed material for real time quantitative polymerase chain reaction (RT-qPCR). Frozen tissue must also have been obtained for fatty acid analysis, reverse phase proteomics, adipokines and cytokines, and RT-qPCR.
• •Subjects must be willing to undergo phlebotomy at baseline, and 6 months and 6.5 months approximately 3 tablespoons of blood will be obtained at baseline, and 6 months and 6.5 months or 6 tablespoons if the subject decides to participate in the optional monocyte cytokine release assay .
• •Subjects must produce a spot urine sample at baseline, 6 months and at study conclusion. Baseline urine sample will in part be used to document that subject is not pregnant.
• •Subjects must be willing to complete questionnaires regarding diet and supplement use, quality of life, relevant family history, personal health and reproductive history and medications at initiation and conclusion of the intervention.
• •Subjects must be willing to sign an informed consent for the entire study and separate consent for repeat RPFNA
• •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 this includes pregnancy, lactation, or stopping or starting hormonal contraceptives..
• •Women who have taken omega 3 fatty acid supplements within 3 weeks prior to their baseline RPFNA.
• •Women who regularly take NSAIDS (\>7 tablets weekly).
• •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.