A Phase II Study of Adjuvant Therapy Using a Regimen of Cyclophosphamide, Paclitaxel With Trastuzumab in Stage I-II HER2/Neu Positive Breast Cancer Patients
This phase II trial studies the side effects and how well cyclophosphamide, paclitaxel, and trastuzumab work when given after surgery in treating patients with stage I-II human epidermal growth factor receptor (HER2/neu) positive breast cancer (confined to the breast or the breast and lymph nodes under the arm). 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, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor cells to grow and spread. Giving cyclophosphamide, paclitaxel, and trastuzumab after surgery may help prevent the cancer from coming back.
• Histologically confirmed newly diagnosed stage I-II HER2/neu positive 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 (no childbearing potential is defined as age 55 years or older and no menses for two years or any age with surgical removal of the uterus and/or both ovaries)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Within 30 days prior to enrollment: Absolute neutrophil count greater than or equal to 1,500/mcl
• Within 30 days prior to enrollment: Platelet count equal to or greater than 150,000/mcl
• Within 30 days prior to enrollment: Hemoglobin \> 11 gm/dl
• Within 30 days prior to enrollment: Alkaline phosphatase equal or less than 1.5 times the upper limit of normal (ULN)
• Within 30 days prior to enrollment: Total bilirubin equal to or less than 1.5 times the ULN
• Within 30 days prior to enrollment: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) no greater than 1.5 times the ULN
• Within 30 days prior to enrollment: Creatinine less than 1.5 times the ULN
• Able to give informed consent
• All included subjects 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