Primary Chemotherapy in Patients With HER2-positive Early Breast Cancer

Inclusion Criteria: * Histologically confirmed breast cancer * T1c N1-2 or T2 N0-2 disease * HER2-positive tumours with 3+ intensity on immunohistochemical staining for HER2 or amplification of the HER2 gene on fluorescence in situ hybridization (FISH) * No prior systemic treatment regimens for breast cancer * Adequate hematologic function (ANC 1500 cells/µl, platelet count 100000/µl, and hemoglobin 8g/dl). * Serum creatinine concentration \< 1.5 times the upper limit of normal (ULN) and/or creatinine clearance \>60 ml/min * Bilirubin level \< 1.5 X ULN * Normal cardiac function with a left ventricular ejection fraction of at least 50% (as assessed by quantitative echocardiogram or MUGA scan) * Karnofsky performance status 80% * Age 18 years * If the patient is of childbearing potential, she agrees to: comply with effective contraceptive measures, has been using adequate contraception since the last menses, will use adequate contraception during the study, and has a negative pregnancy test within one week of study entry * Written informed consent prior to admission to this study Exclusion Criteria: * Male patients * Inflammatory or bilateral breast cancer * Evidence of distant metastases * Previous systemic or local treatment for breast cancer (including surgery, radiotherapy, cytotoxic and endocrine treatments) * Past or current history of other neoplasms, except for * Curatively treated non-melanoma skin cancer * Adequately treated in situ carcinoma of the cervix * Other cancer curatively treated and with no evidence of disease for at least 5 years * Significant cardiac disease, including angina pectoris, severe cardiac arrhythmia requiring medication, severe conduction abnormalities, clinically significant valvular disease, cardiomegaly, ventricular hypertrophy, poorly uncontrolled hypertension (resting diastolic blood pressure \>115 mmHg), prior myocardial infarction, CHF, or other cardiomyopathy * Preexisting sensoric or motor polyneuropathy Grade 2 according to NCI CTC * Serious intercurrent medical or psychiatric illness, including serious active infection * Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study entry. * Detained persons or prisoners * Pregnant or nursing women