Neoadjuvant Letrozole in Treating Postmenopausal Women With Estrogen-Receptor Positive and/or Progesterone-Receptor Positive Stage II, Stage IIIA, or Stage IIIB Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed infiltrating adenocarcinoma of the breast by core needle biopsy
• * Clinical stage T2-T4a-c, N0-2, M0
• Palpable and measurable disease
• Previously untreated disease
• Benefits from neoadjuvant therapy that would improve surgical outcome AND meets criteria for 1 of the following:
• * Marginal candidate for lumpectomy (e.g., lumpectomy feasible but patient at risk for positive margins or poor cosmetic outcome) AND patient desires breast-conserving surgery
• * Ineligible for lumpectomy due to size of primary tumor, but modified radical mastectomy feasible AND patient desires breast-conserving surgery
• * Inoperable disease AND systemic therapy required for disease to become operable by modified radical mastectomy
• Bilateral primary tumors allowed provided both tumors are consistent with entry criteria
• No inflammatory carcinoma (defined as peau d' orange affecting at least one third of the breast)
• * Direct extension of the tumor to the skin allowed
• No metastatic breast disease, except isolated ipsilateral supraclavicular lymphadenopathy
• Hormone receptor status:
• * Estrogen- and/or progesterone-receptor positive disease based on 10% or more nuclear staining of the invasive component of the tumor
• PATIENT CHARACTERISTICS:
• Age
• Postmenopausal
• Sex
• Female
• Menopausal status
• Postmenopausal, defined as meeting 1 of the following criteria:
• * Cessation of menstrual periods for at least 1 year
• * Bilateral surgical oophorectomy
• * Follicle-stimulating hormone and estradiol levels in the postmenopausal range
• Performance status
• ECOG 0-2
• Life expectancy
• Not specified
• Hematopoietic
• Not specified
• Hepatic
• No severe liver dysfunction that would preclude study participation
• Renal
• Not specified
• Other
• Willing and able to provide biopsy material
• Willing to undergo breast surgery after neoadjuvant treatment
• No condition (e.g., confusion, infirmity, or alcoholism) that would preclude study compliance
• No other concurrent active and progressive invasive malignancies
• No other concurrent severe disease that would preclude study participation
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• No concurrent immunotherapy or biological response modifiers for breast cancer
• Chemotherapy
• No prior chemotherapy for breast cancer
• No concurrent chemotherapy for breast cancer
• Endocrine therapy
• At least 2 weeks since prior hormone replacement therapy or phytoestrogenic herbal, alternative, or over-the-counter (OTC) sex hormone remedies
• No prior hormonal agents for breast cancer
• No prior aromatase inhibitors, tamoxifen, raloxifene, or other antiestrogen or selective estrogen receptor modulators
• No concurrent drugs known to affect sex hormone status, including hormone replacement therapy or phytoestrogenic herbal, alternative, or OTC remedies
• No other concurrent endocrine therapy for breast cancer
• Radiotherapy
• No prior radiotherapy for breast cancer
• No concurrent radiotherapy for breast cancer
• Surgery
• Prior sentinel node biopsy allowed
• No other concurrent surgery for breast cancer
• Other
• More than 30 days since prior non-approved or experimental drugs
• Concurrent bisphosphonates for osteoporosis allowed
• No other concurrent treatment for breast cancer