Breast Cancer Clinical Trial
Official title:
Sequential Adjuvant Chemotherapy With Doxorubicin, Taxol, and Cyclophosphamide for Stage II or III Resectable Breast Cancer With Four or More Involved Axillary Lymph Nodes
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 high-dose sequential chemotherapy as
adjuvant therapy in treating patients with stage II or stage III breast cancer who have four
or more positive axillary lymph nodes.
OBJECTIVES: I. Evaluate the efficacy of dose intensive, sequential adjuvant chemotherapy
with doxorubicin, paclitaxel, and cyclophosphamide in patients with stage II/III resected
breast cancer. II. Evaluate the toxicity of this regimen in these patients.
OUTLINE: All patients receive sequential chemotherapy regimens consisting of 3 courses each
of doxorubicin, paclitaxel, and cyclophosphamide on a schedule of one course every 14 days.
Following completion of chemotherapy, patients who underwent breast conservation surgery
receive radiotherapy. Mastectomy patients with 10 or more positive nodes or with T3-4 tumors
are also eligible for delayed radiotherapy. Patients who are hormone receptor positive (or
whose receptor status is unknown) are treated with oral tamoxifen for 5 years, beginning
after completion of all other therapy. Patients are followed every 3 months for 2 years,
every 6 months for 3 years, then yearly.
PROJECTED ACCRUAL: At total of 90 patients will be entered.
;
Primary Purpose: Treatment
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