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

Inclusion Criteria

• •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