Breast, Omega 3 Free Fatty Acid, Ph 0

A Phase 0, Investigator Initiated Study, Evaluating the Impact of Omega 3 Free Fatty Acid Supplementation on Breast Cancer (CTMS# 16-0119)

Assess the impact of dietary omega 3 free fatty acids breast cancer patients.

Prospective, single arm, short term study with correlative biomarker endpoints. Two hundred (200) newly diagnosed breast cancer patients will be recruited to participate in a short term (30 day) Phase 0 biomarker evaluation study prior to surgical resection. Patients will be receive fish Oil (Omega-3 FFAs, 2700 mg by mouth twice daily).

Inclusion Criteria:

• At least 18 years of age
• ECOG ≤2
• Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee
• Consented for tissue collection on CTRC repository 07-32

Exclusion Criteria:

• Active systemic illness (infection including viral illnesses such as Hepatitis and HIV)
• Chronic use of NSAIDs or omega-3 free fatty acid supplementation within the last 60 days (defined as greater than or equal to 7 consecutive days)
• Any NSAIDs or omega-3 free fatty acid supplementation within the last 14 days
• History of medical noncompliance
• Scheduled date of surgical resection that would limit the amount of time taking the intervention to less than 21 days