Breast Cancer Clinical Trial
Official title:
Weekly Paclitaxel During Radiation Therapy for Locally Advanced Breat Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in
chemotherapy use different ways to stop tumor cells from dividing so they stop growing or
die. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of radiation therapy plus paclitaxel in
treating patients with stage IIB or stage III breast cancer.
OBJECTIVES: I. Evaluate the safety and feasibility of twice a week paclitaxel and radiation
therapy in patients with locally advanced breast cancer. II. Determine the pathological
effects of paclitaxel and radiation in locally advanced breast cancer.
OUTLINE: This is a nonrandomized, dual institution study. Patients receive paclitaxel IV
over 1 hour twice a week for a total of 8 weeks. This is started within 1 week of a tumor
biopsy. Patients receive radiotherapy 5 days/week for 5.0 weeks within 1 week of the first
paclitaxel dose. Operable patients who have progressive disease with the above therapy
undergo a modified radical mastectomy (MRM), then receive 4 courses of doxorubicin IV and
cyclophosphamide IV, administered once every 21 days. Inoperable patients receive this same
chemotherapy regimen, then are reevaluated for surgery. Patients who have stable disease or
who respond to the paclitaxel/radiation regimen undergo a MRM, then receive 4 courses of
doxorubicin IV and paclitaxel IV (over 3 hours) once every 21 days. All patients with
hormone receptor positive tumors receive tamoxifen for 5 years after all other therapy is
completed.
PROJECTED ACCRUAL: A total of 40 patients (20 patients per institution) will be accrued over
18- 24 months.
;
Primary Purpose: Treatment
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