Breast Cancer Clinical Trial
Official title:
A Phase II Study in Patients With Metastatic or Locally Advanced Breast Cancer to Evaluate the Worth of the Combination of Adriamycin (Doxorubicin), Taxotere (Docetaxel), and Cyclophosphamide (ATC)
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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