Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Stage III Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00004175
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study Start: 1998-11
• Study First Submitted: 1999-12-10
• Study First Submitted QC: 2004-03-02
• Study First Posted: 2004-03-03
• Primary Completion: 2004-09
• Study Completion: 2005-06
• Disposition First Submitted: 2011-07-01
• Disposition First Submitted QC: 2011-07-01
• Disposition First Posted: 2011-07-14
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-31
• Last Update Posted: 2012-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (4)

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

Albert Einstein Comprehensive Cancer Center; 🇺🇸 Bronx, New York, United States

Monroe Medical Associates; 🇺🇸 Chicago, Illinois, United States

Robert H. Lurie Comprehensive Cancer Center, Northwestern University; 🇺🇸 Chicago, Illinois, United States