Combination Chemotherapy and Paclitaxel Plus Trastuzumab in Treating Women With Palpable Breast Cancer That Can Be Removed by Surgery

Inclusion Criteria:

* Diagnosis of invasive adenocarcinoma by core needle biopsy

  * Fine needle aspiration allowed provided primary tumor size \< 2 cm and lymph node metastases are present
  * Excisional biopsy of the primary tumor allowed provided biopsy-positive lymph nodes are present
* Primary tumor ≥ 2 cm and/or ≥ 1 biopsy-positive lymph node
* HER2-positive disease

  * Confirmation by fluorescent in situ hybridization (FISH) requires gene amplification
  * Confirmation by immunohistochemistry (IHC) requires a strongly positive (3+) staining intensity score
* Ductal carcinoma in situ (DCIS) or synchronous DCIS of the contralateral breast regardless of prior therapy allowed

  * Synchronous invasive breast cancer not allowed
* Ipsilateral DCIS treated by local excision with or without hormonal therapy allowed

  * Those treated with radiation therapy are not allowed
* No definitive clinical or radiologic evidence of metastatic disease
* No history of invasive breast cancer
* Hormone receptor status known
* Menopausal status not specified
* ECOG performance status of 0 -1
* Absolute neutrophil count ≥ 1,200/mm³
* Platelet count ≥ 100,000/mm³
* Total bilirubin normal unless the patient has a grade 1 bilirubin elevation (normal to 1.5 times upper limit of normal \[ULN\]) resulting from Gilbert disease or similar syndrome due to slow conjugation of bilirubin
* Alkaline phosphatase ≤ 2.5 times ULN
* AST ≤ 1.5 times ULN
* Creatinine normal
* Left ventricular ejection fraction (LVEF) ≥ 55 by multi gated acquisition scan (MUGA) or echocardiogram (ECHO) within the past 3 months
* Patients with either skeletal pain or alkaline phosphatase that is \> ULN but ≤ 2.5 times ULN allowed if bone scans fail to demonstrate metastatic disease

  * Suspicious findings on bone scan must be confirmed as benign by x-ray, MRI, or biopsy
* Prior non-breast malignancies allowed if disease-free for 5 years since completion of initial treatment regimen and deemed by their physician to be at low risk for recurrence

  * Patients who had the following cancers are eligible if diagnosed and treated within the past 5 years:

    * Carcinoma in situ of the cervix
    * Colon carcinoma in situ
    * Melanoma in situ
    * Basal cell and squamous cell carcinoma of the skin
* No cardiac disease that would preclude the use of epirubicin hydrochloride or trastuzumab (Herceptin®) including any of the following:

  * Active cardiac disease
  * Angina pectoris that requires the use of antianginal medication
  * Cardiac arrhythmia requiring medication
  * Severe conduction abnormality
  * Clinically significant valvular disease
  * Cardiomegaly on chest x-ray
  * Ventricular hypertrophy on EKG
  * Patient's with poorly controlled hypertension ( i.e., diastolic greater than 100 mm/Hg)

    * Patients with hypertension that is well controlled on medication are eligible
  * History of cardiac disease
  * Myocardial infarction documented as a clinical diagnosis or by EKG or any other tests
  * Documented congestive heart failure
  * Documented cardiomyopathy
* No sensory or motor neuropathy ≥ grade 2, as defined by the NCI's CTCAE v3.0
* Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy
* Women of child bearing potential must have a negative urine or serum pregnancy test within 2 weeks of registration
* Not pregnant or nursing
* No psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
* No non-malignant systemic disease (e.g., cardiovascular, renal, hepatic) that would preclude treatment with either of the treatment regimens
* No prior surgical axillary staging procedure

  * Prior non-excisional biopsy of an axillary node allowed
* No prior treatment for this breast cancer

  * Hormonal therapy allowed if had been given for up to a total of 28 days anytime after diagnosis and before study entry
  * Hormonal therapy must stop at or before study entry and be re-started, if indicated, following surgery
* No prior therapy with anthracyclines or taxanes for any malignancy
* No other investigational agents within the past 30 days
* No concurrent sex hormonal therapy (e.g., birth control pills, ovarian hormonal replacement therapy)
* No concurrent therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulator (SERM), either for osteoporosis or breast cancer prevention