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
• •* 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