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

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