Impact of Omega 3 Fatty Acid Supplementation on Aromatase in Obese Subjects

Prospective, comparative, three arm, short term, non-interventional study with correlative
biomarker endpoints. Sixty (60) obese (≥ 30 BMI) newly diagnosed ER+ postmenopausal breast
cancer patients will be recruited to participate in a short term (30 day) Phase 0 biomarker
evaluation study prior to surgical resection.

Inclusion Criteria:

- At least 18 years of age.

- Postmenopausal as confirmed in medical history

- Ability to understand the purposes and risks of the study and has signed a written
informed consent form approved by the investigator's IRB (Institutional Review
Board)/Ethics Committee.

- Estrogen receptor positive breast cancer. Body mass index of 30 or greater.

- Consented for tissue collection on CTRC (Cancer Therapy and Research Center)
repository 07-32

Exclusion Criteria:

- Cachexia

- Active systemic illness (infection including viral illnesses such as Hepatitis and
HIV)

- Chronic use of NSAIDs (nonsteroidal anti-inflammatory drugs) aspirin or omega-3 free
fatty acid supplementation within the last 60 days (defined as greater than or equal
to 7 consecutive days)

- Any NSAIDs aspirin 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