Cyclophosphamide and Paclitaxel With or Without Trastuzumab in Stage I-II Breast Cancer Who Have Undergone Surgery

Inclusion Criteria:

Histologically confirmed newly diagnosed stage I-II breast cancer
Women of reproductive potential must be non-pregnant and non-nursing and must agree to employ an effective barrier method of birth control throughout the study and for up to 6 months following treatment
Women of child-bearing potential must have a negative pregnancy test within 7 days of initiating study
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Absolute neutrophil count greater than or equal to 1,500/mcl
Platelet count equal to or greater than 150,000/mcl
Hemoglobin > 11 gm/dl
Alkaline phosphatase equal or less than 1.5 times the upper limit of normal (ULN)
Total bilirubin equal to or less than 1.5 times the ULN
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) no greater than 1.5 times the ULN
Creatinine less than 1.5 times the ULN
Able to give informed consent
All included patients must have normal cardiac function as defined by an ejection fraction of > 50% by echocardiogram
Able to return for treatment and follow-up on the specified days

Exclusion Criteria:

Prior malignancy; except for adequately treated basal cell or squamous cell skin cancer or noninvasive carcinomas
Patients with preexisting grade II peripheral neuropathy
Patients with prior chemotherapy
Stage IV or metastatic breast cancer
Pregnant or nursing women
Inability to cooperate with treatment protocol
No active serious infections or other conditions precluding chemotherapy
Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol (e.g. unstable angina, myocardial infarction within 6 months, severe infection, etc.)
Known hypersensitivity to any component of required drugs in the study
Known positive for human immunodeficiency virus (HIV) or infectious hepatitis, type A, B or C or active hepatitis
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) class III or IV heart failure uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities; prior to study entry, any electrocardiograph (ECG) abnormality at screening has to be documented by the investigator as not medically relevant