Chemotherapy or Letrozole Before Surgery in Treating Postmenopausal Women With Breast Cancer That Can Be Removed By Surgery

DISEASE CHARACTERISTICS:

• Histologically proven primary invasive breast cancer that is thought to be suitable for neoadjuvant treatment

  • No cytological proof of malignancy only
  • T2 tumor or greater (≥ 20 mm by ultrasound) or any T stage with nodal disease ≥ 20 mm diameter on ultrasound assessment
  • No evidence of distant metastatic disease as disclosed by bone scan, liver, and chest imaging
• Definite indication for neoadjuvant and adjuvant chemotherapy
• Primary tumor amenable to biopsy
• No inoperable disease that is judged very unlikely to be rendered operable by neoadjuvant treatment
• No inflammatory breast cancer
• No bilateral invasive breast cancer
• HER-2 positivity is NOT an exclusion criterion in the feasibility (pilot) study

• Estrogen receptor (ER) positive tumor

  • No ER-poor disease as defined locally (e.g., H-score < 100, Allred 3/4/5)
  • Allred 6/7/8, H-score H ≥100 allowed

PATIENT CHARACTERISTICS:

• Postmenopausal, meeting 1 of the following criteria:

  • Over 12 months since last menstrual period
  • Postmenopausal gonadotrophin levels (luteinizing hormone or follicle-stimulating hormone levels above local criteria)
  • Postmenopausal estradiol levels below local criteria
  • Prior bilateral oophorectomy
  • Menopause induced by gonadotrophin-releasing hormone not allowed
• WHO performance status 0 or 1
• WBC ≥ 3.0 × 10^9/L
• ANC ≥ 1.5 × 10^9/L
• Platelets ≥ 100 × 10^9/L
• Hemoglobin > 9 g/dL
• AST/ALT ≤ 1.5 times upper limit of normal (ULN)
• Serum bilirubin ≤ 1.5 times ULN
• Alkaline phosphatase ≤ 1.5 times ULN
• Serum creatinine ≤ 1.5 times ULN
• No active, uncontrolled infection

• No malignancy within the past 10 years except for basal cell carcinoma or cervical carcinoma in situ

  • Treatment for previous malignancy confined to resection alone
• No concomitant medical, psychiatric, or geographic problems that might prevent completion of treatment or follow-up
• No known severe hypersensitivity to aromatase inhibitors
• No contraindication to receiving aromatase inhibitors (clinical evidence or recorded history of osteoporosis)

• No other serious illness or medical condition including any of the following:

  • Congestive heart failure or unstable angina pectoris
  • Myocardial infarction within the past year
  • Uncontrolled hypertension or high-risk uncontrolled arrhythmias
  • History of significant neurologic or psychiatric disorders, including psychotic disorders, dementia, or seizures, that would prohibit the understanding and giving of informed consent
  • Active peptic ulcer
  • Unstable diabetes mellitus
• No definite contraindications for the use of corticosteroids
• No contraindication to receiving combination anthracycline/taxane chemotherapy
• Willing to undergo repeat biopsies

PRIOR CONCURRENT THERAPY:

• No hormone replacement therapy within 4 weeks of starting treatment
• No chronic oral treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose (≤ 20 mg methylprednisolone or equivalent)
• No concurrent warfarin or heparin therapy