A Phase II Study of Adjuvant Therapy Using a Regimen of Cyclophosphamide, Paclitaxel With or Without Trastuzumab in Stage I-II Breast Cancer Patients
I. To determine the toxicities and ability to complete the planned treatment of a dose-dense
regimen of cyclophosphamide and paclitaxel with or without trastuzumab in patients with
newly diagnosed stage I-II breast cancer.
II. To estimate recurrence free survival of a dose-dense regimen of cyclophosphamide and
paclitaxel with or without trastuzumab in patients with newly diagnosed stage I-II breast
SYSTEMIC CHEMOTHERAPY: Patients receive cyclophosphamide intravenously (IV) over 1 hour and
paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the
absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY (Her-2 neu positive patients): Patients receive trastuzumab IV over 30
minutes on day 1. Treatment repeats every 14 days for 5 courses and then every 21 days for
14 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically for 3 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary toxicity (i.e., neutropenia)
Evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0. Descriptive statistics will be computed for all variables to examine data quality. Variable distributions will be examined using stem-and-leaf plots, means, medians, standard deviations, ranges and frequencies, and 90% confidence intervals. Descriptive statistics, including 90% confidence intervals, will also be examined for subjects treated with and without trastuzumab for patients with stage I and II disease.
Up to 7 years
University of Nebraska
United States: Institutional Review Board
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center||Omaha, Nebraska 68198-7680|
|Saint Francis Medical Center||Grand Island, Nebraska 68802|