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

This is an interventional prevention trial for Breast Cancer focused on measuring breast cancer, atypical ductal breast hyperplasia, lobular breast carcinoma in situ, ductal breast carcinoma in situ, breast cancer prevention, high risk breast cancer Read More

• 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