Letrozole in Treating Healthy Postmenopausal Women at High Risk for Breast Cancer

Inclusion Criteria:

• Healthy postmenopausal women at "high risk" for breast cancer will be eligible for the study; definition of menopause will be:

  • Amenorrhea for at least 12 months, or
  • History of hysterectomy and bilateral salpingo-oophorectomy, or
  • At least 55 years of age with prior hysterectomy with or without oophorectomy, or
  • Age 35 to 54 with a prior hysterectomy without oophorectomy OR with a status of ovaries unknown with documented follicle-stimulating hormone level demonstrating elevation in postmenopausal range

  • "High risk" for breast cancer will be defined as:

    • Prior histologically confirmed lobular carcinoma in situ (LCIS) treated by local excision only, or
    • At least 1.66% probability of invasive breast cancer within 5 years using the Breast Cancer Risk Assessment Tool (http://www.cancer.gov/bcrisktool/)
• ECOG performance status 0 or 1 Karnofsky 80% or above
• Leukocytes >= 3,000/uL
• Absolute neutrophil count >= 1,500/uL
• Platelets >= 100,000/uL
• Total bilirubin =< 2.0 mg/dL
• AST (SGOT)/ALT (SGPT) =< 2.0 X institutional ULN
• Creatinine =< 1 X institutional ULN
• Recent mammogram negative for breast cancer, BIRADS score < 3 (within the last 12 months)
• Ability to understand and the willingness to sign a written informed consent document; only potential participants with the ability to understand and the willingness to sign a written document will be presented with an informed consenting document

Exclusion Criteria:

• Women diagnosed with osteoporosis (previously or on screening DEXA for this study) and not on a stable dose of long or short-acting bisphosphonates therapy for at least 3 months will be excluded from the study; women diagnosed with osteoporosis and on raloxifene (Evista) therapy will be excluded from the study; use of calcium and/or vitamin D for osteoporosis prevention or treatment is allowed; women with osteopenia will be allowed to participate in this study
• Have had invasive cancer within the past five years except non-melanoma skin cancer
• Evidence of suspicious of malignant disease on bilateral mammogram within the past year unless ruled out by further evaluation
• History of prior invasive breast cancer or intraductal carcinoma in situ, or history of prior radiation therapy to the chest or breast
• Participants may not be receiving any other investigational agents; participants may not be concurrently enrolled in another breast cancer prevention intervention trial
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to letrozole
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Within 3 months since prior estrogen or progesterone replacement therapy, oral contraceptives, androgens, luteinizing hormone-releasing hormone analogs, prolactin inhibitors, or antiandrogens
• Within 3 months since prior tamoxifen, raloxifene, or other selective estrogen-receptor modulators
• Within 3 months since regular use (more than 2 times a week) of prior estrogenic supplements or herbal remedies
• History of bleeding or clotting disorder; current or recent (within 3 months) use of Coumadin, Plavix or other systemic anticoagulant other than aspirin is not permitted if subject chooses to participate in the optional RPFNA procedure; if a subject chooses not to participate in the RPFNA procedure, prior or current treatment with systemic anticoagulants is permitted