Radiation Therapy Plus Paclitaxel in Treating Patients With Stage IIB or Stage III Breast Cancer
NCT ID: NCT00003050
Last Updated: 2014-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
46 participants
INTERVENTIONAL
1997-04-30
2000-03-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of radiation therapy plus paclitaxel in treating patients with stage IIB or stage III breast cancer.
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Detailed Description
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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.
Conditions
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Study Design
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TREATMENT
Interventions
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cyclophosphamide
doxorubicin hydrochloride
paclitaxel
tamoxifen citrate
surgical procedure
radiation therapy
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant Fertile patients must use effective contraception during and 6 months after treatment Medically and psychologically stable
PRIOR CONCURRENT THERAPY: No prior therapy of any type
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Darcy V. Spicer, MD
Role: STUDY_CHAIR
University of Southern California
Locations
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USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Countries
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References
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Adams S, Chakravarthy AB, Donach M, Spicer D, Lymberis S, Singh B, Bauer JA, Hochman T, Goldberg JD, Muggia F, Schneider RJ, Pietenpol JA, Formenti SC. Preoperative concurrent paclitaxel-radiation in locally advanced breast cancer: pathologic response correlates with five-year overall survival. Breast Cancer Res Treat. 2010 Dec;124(3):723-32. doi: 10.1007/s10549-010-1181-8. Epub 2010 Sep 29.
Formenti SC, Volm M, Skinner KA, Spicer D, Cohen D, Perez E, Bettini AC, Groshen S, Gee C, Florentine B, Press M, Danenberg P, Muggia F. Preoperative twice-weekly paclitaxel with concurrent radiation therapy followed by surgery and postoperative doxorubicin-based chemotherapy in locally advanced breast cancer: a phase I/II trial. J Clin Oncol. 2003 Mar 1;21(5):864-70. doi: 10.1200/JCO.2003.06.132.
Formenti SC, Symmans WF, Volm M, Skinner K, Cohen D, Spicer D, Danenberg PV. Concurrent paclitaxel and radiation therapy for breast cancer. Semin Radiat Oncol. 1999 Apr;9(2 Suppl 1):34-42.
Other Identifiers
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LAC-USC-1B972
Identifier Type: -
Identifier Source: secondary_id
NCI-G97-1304
Identifier Type: -
Identifier Source: secondary_id
CDR0000065692 (1B-97-2)
Identifier Type: -
Identifier Source: org_study_id
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