Multi-Cycle High-Dose Chemotherapy Versus Optimized Conventionally-Dosed Chemotherapy in Patients With Metastatic Breast Cancer: A Phase II Prospective Randomized Trial
OBJECTIVES: I. Compare the efficacy of multi-course high-dose chemotherapy with autologous
peripheral blood stem cell transplantation versus standard-dose chemotherapy in women with
metastatic breast cancer. II. Compare the five year event-free survival, in terms of time to
progression or time to death due to toxic effects, in patients treated with these regimens.
III. Compare the response rate and overall survival of patients treated with these regimens.
IV. Compare the toxicity of these regimens in this patient population.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two
treatment arms. Arm I: Patients receive docetaxel and doxorubicin once followed by
filgrastim (G-CSF) daily for approximately 1 week. Treatment repeats approximately every 3
weeks for 4 courses. Patients then receive cyclophosphamide, methotrexate, and fluorouracil
on days 7 and 8 every 4 weeks for 4 courses. Arm II: Patients receive docetaxel,
doxorubicin, and G-CSF as in arm I for 3 courses. Patients undergo leukapheresis daily for 3
or 4 days. Patients then receive 1 course of ifosfamide, etoposide, and carboplatin daily
for 4 days when blood counts recover, followed by 1 course of cyclophosphamide and thiotepa
daily for 4 days. Patients undergo peripheral blood stem cell reinfusion following each
PROJECTED ACCRUAL: A total of 264 patients (132 per arm) will be accrued for this study.
Primary Purpose: Treatment
Linda T. Vahdat, MD
Herbert Irving Comprehensive Cancer Center
United States: Federal Government
|Herbert Irving Comprehensive Cancer Center||New York, New York 10032|