A Pilot Study to Evaluate the Effects of Omega-3 Fatty Acids on Intermediate Markers of Breast Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- At increased risk of developing breast cancer, as defined by 1 of the following
criteria:

- 5-year Gail risk ≥ 1.7%

- Calculated 5-year Gail risk ≥ 5 times the average for age group, as defined by 1
of the following:

- At least 0.1% (for patients age 20-29)

- At least 1.0% (for patients age 30-39)

- At least 1.7% (for patients age 40 and over)

- Known BRCA1 or BRCA2 mutation carrier

- Family history consistent with hereditary breast cancer, as defined by any of
the following:

- At least 4 relatives diagnosed with breast cancer at any age

- At least 2 first-degree relatives diagnosed with breast cancer at age 50 or
younger

- Breast and ovarian cancer diagnosed in the same relative

- At least 2 occurrences of breast cancer and 1 occurrence of ovarian cancer
at any age in the same family

- Atypical hyperplasia or lobular carcinoma in situ of the breast by prior biopsy

- History of unilateral ductal carcinoma in situ of the breast

- History of invasive stage I breast cancer in remission (completed local and
systemic standard therapy)

- History of ovarian cancer in remission for > 5 years

- Baseline mammogram performed within the past 6 months with an interpretation of not
suspicious for malignancy (BIRAD 1-3)

- Not eligible for OR refused standard breast cancer risk reduction strategies (e.g.,
prophylactic oophorectomy, prophylactic mastectomy, or tamoxifen)

PATIENT CHARACTERISTICS:

Age

- 18 and over

Sex

- Female

Menopausal status

- Not specified

Performance status

- SWOG 0-1

Life expectancy

- Not specified

Hematopoietic

- Absolute granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 8.0 g/dL

Hepatic

- SGOT and/or SGPT ≤ 2.5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2.5 times ULN

- Bilirubin ≤ 2.0 times ULN

Renal

- Creatinine ≤ 2.0 mg/dL

Other

- Not pregnant or nursing

- Negative pregnancy test

- No underlying medical, psychiatric, or social condition that would preclude study
participation

- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- More than 6 months since prior and no concurrent hormonal therapy, including any of
the following:

- Antiestrogens

- Estrogen

- Selective estrogen-receptor modulators

- Progestins

- Aromatase inhibitors

- Hormonal contraceptives

Radiotherapy

- Not specified

Surgery

- No prior bilateral mastectomy

Other

- More than 3 months since prior and no concurrent chronic (i.e., > 3 times per week)
non-steroidal anti-inflammatory drugs (e.g., aspirin, ibuprofen, or indomethacin) or
cyclooxygenase-2 inhibitors

- No prior cancer treatment that would preclude study treatment