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Spots Global Cancer Trial Database for Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Stage III Breast Cancer

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We do not endorse or review these studies in any way.

Trial Identification

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

Conditions

Breast Cancer

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: William J. Gradishar, MD

Affiliation: Robert H. Lurie Cancer Center

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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