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