Docetaxel, Epirubicin, and Cyclophosphamide With or Without Trastuzumab in Treating Women With Locally Advanced Breast Cancer That Can Be Removed By Surgery

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed primary carcinoma of the breast by core biopsy

• Solitaire or multifocal disease, defined as tumor manifestations within a quadrant or distance between tumor manifestations measured bilaterally < 4 cm, respectively

  • No multifocal primary tumor, defined as tumor manifestations in different quadrants or distance between tumor manifestations ≥ 4 cm

• Locally advanced, operable disease

  • Primary tumor ≥ 2 cm by clinical examination or imaging (i.e., mammogram, MRI, or ultrasound)

    • Inflammatory breast cancer with bidimensionally measurable lesion, independent of nodal status, allowed

• HER2 status meeting 1 of the following criteria:

  • HER2-positive disease

    • 3+ by immunohistochemistry (IHC) and/or positive by fluorescence in situ hybridization (FISH)

  • HER-2 negative disease

    • 0 or 1+ by IHC OR 2+ by IHC and negative by FISH
• No distant metastases by clinical or imaging diagnosis
• No prior breast cancer
• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Female
• Pre- or post-menopausal
• ECOG performance status 0-2
• Platelet count ≥ 100,000/mm^3
• Neutrophil count ≥ 1,500/mm^3
• Hemoglobin ≥ 10 g/dL
• ALT and AST ≤ 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2.5 times ULN
• Creatinine ≤ 1.5 times ULN
• Bilirubin normal (unless due to clearly documented Gilbert's syndrome)
• Not pregnant or nursing
• Negative pregnancy test (for premenopausal women or women with a postmenopausal status for < 1 year)
• Fertile patients must use effective contraception
• Adequate organ function for cytotoxic chemotherapy
• No known hypersensitivity reaction to the study agents or incorporated substances
• No known allergy or severe reactions to trastuzumab or its constituents (for patients with HER2-positive disease)
• No preexisting motor or sensory neuropathy ≥ grade 2
• No other invasive malignancy within the past 5 years that would preclude study compliance or affect the interpretation of study results
• LVEF ≥ 55% by MUGA or echocardiography

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

  • New York Heart Association class II-IV congestive heart failure
  • History of documented congestive heart failure
  • Unstable angina pectoris
  • Myocardial infarction within the past 12 months
  • Uncontrolled hypertension (i.e., systolic blood pressure [BP] > 180 mm Hg or diastolic BP > 100 mm Hg)
  • Clinically significant valvular heart disease
  • High-risk, uncontrolled arrhythmias
  • Dyspnea at rest due to malignant or other disease
  • Condition that requires supportive oxygen therapy
  • Active serious uncontrolled infections
  • Uncontrolled diabetes

PRIOR CONCURRENT THERAPY:

• No prior systemic therapy for cancer
• No prior trastuzumab (Herceptin^®) (for HER2-positive patients)
• No other concurrent anticancer therapy
• No other concurrent investigational drugs
• No concurrent immunosuppressive therapy
• No concurrent sex hormones
• No concurrent corticosteroids unless for premedication
• No concurrent bisphosphonates during active treatment with chemotherapy