Phase II Study of Taxotere, Doxorubicin and Cyclophosphamide (TAC) Primary Therapy in Stage III Breast Cancer
OBJECTIVES: I. Determine the clinical response rate to docetaxel, doxorubicin, and
cyclophosphamide as primary therapy in women with stage III breast cancer. II. Determine the
pathologic complete response rate to this treatment regimen in this patient population. III.
Assess the side effects and toxicity profile of this treatment regimen in these patients.
OUTLINE: This is an open label, multicenter study. Patients receive doxorubicin IV over 5-10
minutes followed by cyclophosphamide IV over 5-10 minutes and docetaxel IV over 1 hour.
Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or
unacceptable toxicity. Within 5 weeks following completion of chemotherapy, operable
patients achieving complete or partial response undergo mastectomy, segmental mastectomy, or
lumpectomy with nodal dissection. Patients with positive surgical tumor margins may undergo
an additional surgical procedure. Patients are followed for survival.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 1 year.
Primary Purpose: Treatment
William J. Gradishar, MD
Robert H. Lurie Cancer Center
United States: Federal Government
|Albert Einstein Comprehensive Cancer Center
|Bronx, New York 10461
|Stanford University Medical Center
|Stanford, California 94305-5408
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University
|Chicago, Illinois 60611
|Monroe Medical Associates
|Chicago, Illinois 60603