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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Start Date
April 1, 1997
Primary Completion Date
March 1, 2000
Completion Date
March 1, 2000
Last Updated
May 22, 2014
46
ACTUAL participants
cyclophosphamide
DRUG
doxorubicin hydrochloride
DRUG
paclitaxel
DRUG
tamoxifen citrate
DRUG
surgical procedure
PROCEDURE
radiation therapy
RADIATION
Lead Sponsor
University of Southern California
Collaborators
NCT05673200
NCT05372640
Data Source & Attribution
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