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Brief Title: Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Stage III Breast Cancer
Official Title: Phase II Study of Taxotere, Doxorubicin and Cyclophosphamide (TAC) Primary Therapy in Stage III Breast Cancer
Study ID: NCT00004175
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining docetaxel, doxorubicin, and cyclophosphamide in treating women who have previously untreated stage III breast cancer.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Stanford University Medical Center, Stanford, California, United States
Monroe Medical Associates, Chicago, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States
Albert Einstein Comprehensive Cancer Center, Bronx, New York, United States
Name: William J. Gradishar, MD
Affiliation: Robert H. Lurie Cancer Center
Role: STUDY_CHAIR