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