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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
89
600 mg/m2, IV, every 3 weeks
60 mg/m2, IV, every 3 weeks
60 mg/m2, IV, every 3 weeks
Best over-all tumor response that occurs during 6 cycles of chemotherapy
Time frame: 18 weeks
Survival
Time frame: 18 weeks
Time to first response
Time frame: 18 weeks
Time to progression
Time frame: 18 weeks
Duration of response
Time frame: 18 weeks
Completion of at least four cycles of chemotherapy
Time frame: 12 weeks
Toxicity profile
Time frame: 18 weeks
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