A Study Evaluating the Effect of Flaxseed on Biomarkers of Breast Cancer Risk

Inclusion Criteria

- Patients enrolled in must meet ≥ 1 of the following criteria:

- History of unilateral or bilateral atypical ductal hyperplasia with or without
family history

- History of atypical lobular hyperplasia or lobular carcinoma in situ with or
without family history

- History of ductal carcinoma in situ

- Prior stage I breast cancer allowed provided it was adequately treated and
therapy was completed ≥ 1 year ago

- Lifetime risk for developing breast cancer > 20% (based on Gail or Claus model)

- No abnormal mammogram requiring short-term follow-up within the past 6 months

- No severe atypia or carcinoma cells on RPRNA

PATIENT CHARACTERISTICS:

- Premenopausal

- ECOG performance status 0-1

- Patients enrolled must meet the following criteria:

- No peri- or postmenopausal status as determined by estradiol levels < 20 ng/dL
and FSH levels > 45 ng/dL

- No thrombocytopenia (defined as platelet count < 50,000/mm^3)

- Creatinine ≤ 1.5 mg/dL

- Not pregnant or nursing

- Fertile patients must use effective contraception consistently

- No other prior malignancy allowed except for the following:

- Basal cell or squamous cell carcinoma

- In situ cervical cancer

- No history of any of the following conditions within the past 5 years:

- Crohn disease

- Ulcerative colitis

- Inflammatory bowel disease

- Irritable bowel syndrome

- Celiac sprue

- Malabsorption syndrome

- Diverticulitis

- Diverticulosis

- No allergy to flaxseed, other seeds or nuts, or wheat

PRIOR CONCURRENT THERAPY:

- Patients enrolled in part 1 must meet the following criteria:

- No prior breast implants or tram-flap reconstruction

- Breast reduction allowed

- No prior neoadjuvant chemotherapy or other chemotherapy within the past year

- No prior neoadjuvant hormonal therapy

- No prior whole radiation to the contralateral breast undergoing random
periareolar fine needle aspiration (RPFNA)

- No concurrent coumadin or other chronic anticoagulants (even if they are held
for surgery)

- Patients enrolled in part 2 must meet the following criteria:

- More than 1 year since prior chemotherapy and adjuvant hormonal therapy for
breast cancer

- No concurrent chemotherapy for breast cancer

- At least 1 month since prior and no concurrent treatment with corticosteroid

- At least 2 weeks since prior and no concurrent use of antibiotics

- At least 2 weeks

- No history of chest wall irradiation

- No presence of breast implants

- No prior or concurrent tamoxifen within the past 90 days

- No chronic/concurrent medications that inhibit platelet function, including any
of the following:

- Aspirin

- Non-steroidal anti-inflammatory drugs (i.e., Aleve®, Motrin®, ibuprofen)

- Coumadin

- Heparin

- Low molecular weight heparin

- Anti-platelet agents

- No prior short-term use of platelet inhibitors ≥ 7 days prior to RPFNA

- No concurrent ingestion of the following:

- Pumpkin seeds

- Sesame seeds

- Fish oil supplements

- At least 30 days since prior and no concurrent flaxseed supplements, fish oil,
or flaxseed oil

- No concurrent treatment for another malignancy