Cyclophosphamide and Paclitaxel With or Without Trastuzumab in Stage I-II Breast Cancer Who Have Undergone Surgery
Condition: Stage IA Breast Cancer; Stage IB Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: cyclophosphamide; paclitaxel; trastuzumab; laboratory biomarker analysis
Intervention description: Given IV; Given IV; Given IV; Correlative studies
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 112.0
Sex: Female
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This phase II trial studies the side effects and how well giving cyclophosphamide and
      paclitaxel with or without trastuzumab works in treating patients with stage I-II breast
      cancer who have undergone surgery. Drugs used in chemotherapy, such as cyclophosphamide and
      paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the
      cells or by stopping them from dividing. Giving monoclonal antibody therapy, such as
      trastuzumab, with chemotherapy may kill more tumor cells. Giving these treatments after
      surgery may kill any tumor cells that remain after surgery.
    

Eligibility criteria:

        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