Combination Chemotherapy in Treating Women With Stage IIIB or Stage IV Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00003352
- Lead Sponsor
- NSABP Foundation Inc
- 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 combination chemotherapy consisting of doxorubicin, cyclophosphamide, and docetaxel in treating women with stage IIIB or stage IV breast cancer.
- Detailed Description
OBJECTIVES: I. Determine the overall response rate to doxorubicin, docetaxel, and cyclophosphamide (ATC) in women with metastatic or locally advanced breast cancer. II. Determine survival, time to first response, time to progression, and duration of response in these patients. III. Evaluate the feasibility of administering ATC for at least 4 courses. IV. Evaluate the toxicity profile of ATC and its effect on cardiac function.
OUTLINE: Patients receive intravenous doxorubicin over 15 minutes on day 0, followed by intravenous cyclophosphamide over 30 minutes. An hour after the end of the doxorubicin infusion, intravenous docetaxel is administered over 1 hour. Patients receive courses every 21 days until disease progression or unacceptable toxic effects are observed. When the maximum dose of doxorubicin is reached, treatment continues with docetaxel and cyclophosphamide. Patients with locally advanced breast cancer receive chemotherapy for at least 2 courses after documented response. Patients are followed every 6 weeks.
PROJECTED ACCRUAL: Approximately 89 patients will be accrued to this study within 14 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 89
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Best over-all tumor response that occurs during 6 cycles of chemotherapy 18 weeks
- Secondary Outcome Measures
Name Time Method Survival 18 weeks Time to first response 18 weeks Time to progression 18 weeks Completion of at least four cycles of chemotherapy 12 weeks Toxicity profile 18 weeks Duration of response 18 weeks
Trial Locations
- Locations (166)
Baptist Medical Center - Birmingham
🇺🇸Birmingham, Alabama, United States
Huntsville Hospital System
🇺🇸Huntsville, Alabama, United States
MBCCOP - University of South Alabama
🇺🇸Mobile, Alabama, United States
CCOP - Greater Phoenix
🇺🇸Phoenix, Arizona, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Beckman Research Institute, City of Hope
🇺🇸Duarte, California, United States
Scripps Clinic and Research Foundation - La Jolla
🇺🇸La Jolla, California, United States
University of California San Diego Cancer Center
🇺🇸La Jolla, California, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Saint Mary Medical Center - Long Beach
🇺🇸Long Beach, California, United States
Scroll for more (156 remaining)Baptist Medical Center - Birmingham🇺🇸Birmingham, Alabama, United States