A Phase II Study of Cyclophosphamide, Thiotepa, and Carboplatin (CTC) as a Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation in Patients With Breast Cancer
OBJECTIVES: I. Determine long term remission rates as measured by disease free survival in
women with breast cancer treated with cyclophosphamide, thiotepa, and carboplatin followed
by autologous hematopoietic stem cell transplantation. II. Determine the safety and efficacy
of this combination chemotherapy regimen in this patient population.
OUTLINE: Peripheral blood stem cells (PBSC) are collected. Patients sequentially receive
cyclophosphamide IV over 1 hour, thiotepa IV over 1 hour, and carboplatin IV over 1 hour on
days -6 to -4. PBSC are reinfused on day 0. Patients are followed at 3 months, 6 months, 1
year, and then annually thereafter.
PROJECTED ACCRUAL: At least 40 patients with 4-9 positive lymph nodes and at least 50
patients with 10 positive lymph nodes will be accrued for this study.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
relapse free survival determined by the Kaplan-Meier product-limit method
five years post transplant
Claudio Anasetti, MD
Moffitt Cancer Center
United States: Federal Government
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|Halifax Medical Center||Daytona Beach, Florida 32114|
|Florida Cancer Specialists||Fort Myers, Florida 33901|