Omega-3 Fatty Acid in Treating Patients With Stage I-III Breast Cancer

PRIMARY OBJECTIVES:

I. To determine if omega-3 dietary supplementation (omega-3 fatty acid) results in higher
polyunsaturated fatty acids (PUFA) levels in surgical specimens of normal and malignant
breast tissue in women who took omega 3 tablets in comparison to those who took placebo.

II. To determine if omega-3 dietary supplementation results in higher PUFA levels in plasma
and red blood cells in women who took omega 3 tablets in comparison to those who took
placebo.

III. To determine if omega-3 dietary supplementation affects the metabolites of omega-3 and
omega-6 PUFA in surgical specimens of malignant and normal breast tissue in comparison to
controls.

IV. To determine if women who take omega-3 dietary supplementation have less proliferation
and greater apoptosis in malignant breast tissue in comparison to women who take placebo.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive omega-3 fatty acid orally (PO) daily for 7-14 days.

ARM II: Patients receive placebo PO daily for 7-14 days.

Inclusion Criteria:

- Newly diagnosed stage I to III breast cancer and carcinoma in situ (including lobular
carcinoma in situ [LCIS] and ductal carcinoma in situ [DCIS])

- Breast surgery (lumpectomy or mastectomy) is planned for at least 7 days from the day
of enrollment

- Ability to understand and the willingness to sign an Institutional Review Board
(IRB)-approved written informed consent document

- Tumor measures at least 1 centimeter on imaging or physical exam

Exclusion Criteria:

- Any patient with surgery scheduled < 7days after biopsy

- Patients who are unable to refrain from the use of any NSAID or full-dose
acetylsalicylic acid (ASA)-containing NSAID while taking study drug

- Patients who will receive neoadjuvant chemotherapy are not eligible

- Patients who are currently taking omega-3 fatty acids, as they are unable to be
randomized to placebo

- Patients who have previously taken omega-3 fatty acid within 1 month prior to study
enrollment

- Patients with an allergy or known hypersensitivity to fish