Flaxseed in Preventing Breast Cancer in Premenopausal Women at Risk of Developing Breast Cancer

• 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