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

Inclusion Criteria

• •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