SWOG 8897-A DNA Analysis in Predicting Treatment Outcome in Women With Breast Cancer in SWOG 8897
NCT ID: NCT00896623
Last Updated: 2017-02-17
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
1577 participants
OBSERVATIONAL
2006-12-31
2007-06-30
Brief Summary
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PURPOSE: This laboratory study is looking at DNA in tissue samples from women with breast cancer to see if it can predict treatment outcome.
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Detailed Description
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* Determine if polymorphisms resulting in greater activation of cyclophosphamide (CYP2B6, CYP3A4, and CYP3A5) are associated with disease-free survival and treatment toxicities in women with breast cancer.
* Determine if polymorphisms resulting in less production of quinone-related oxidative damage of doxorubicin hydrochloride (NQO1, NQO2, NOS2, NOS3, CBR3) are associated with disease-free survival and treatment toxicities in these patients.
OUTLINE: This is a multicenter study.
Tissue samples archived on clinical trial SWOG-8897 are genotyped for polymorphisms in the CYP3A4, CYP3A5, CYP2B6, NQO1, NQO2, NOS2, NOS3, and CBR3 genes by matrix-assisted laser desorption ionization-time-of-flight mass spectrometry. Variant alleles are correlated with patient outcome.
PROJECTED ACCRUAL: A total of 1,577 patients will be accrued for this study.
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Interventions
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mutation analysis
polymorphism analysis
surface-enhanced laser desorption/ionization-time of flight mass spectrometry
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of breast cancer
* Node-negative breast cancer
* Enrolled on clinical trial SWOG-8897
* Archived tissue from patients with normal lymph nodes in the low-risk group receiving no treatment and those in the intermediate group receiving treatment
* Hormone receptor status known
PATIENT CHARACTERISTICS:
* Female
* Pre- or post-menopausal
PRIOR CONCURRENT THERAPY:
* Not specified
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Christine B. Ambrosone, PhD
Role: STUDY_CHAIR
Roswell Park Cancer Institute
References
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Yao S, Barlow WE, Albain KS, Choi JY, Zhao H, Livingston RB, Davis W, Rae JM, Yeh IT, Hutchins LF, Ravdin PM, Martino S, Lyss AP, Osborne CK, Abeloff MD, Hortobagyi GN, Hayes DF, Ambrosone CB. Manganese superoxide dismutase polymorphism, treatment-related toxicity and disease-free survival in SWOG 8897 clinical trial for breast cancer. Breast Cancer Res Treat. 2010 Nov;124(2):433-9. doi: 10.1007/s10549-010-0840-0. Epub 2010 Mar 23.
Yao S, Barlow WE, Albain KS, Choi JY, Zhao H, Livingston RB, Davis W, Rae JM, Yeh IT, Hutchins LF, Ravdin PM, Martino S, Lyss AP, Osborne CK, Abeloff M, Hortobagyi GN, Hayes DF, Ambrosone CB. Gene polymorphisms in cyclophosphamide metabolism pathway,treatment-related toxicity, and disease-free survival in SWOG 8897 clinical trial for breast cancer. Clin Cancer Res. 2010 Dec 15;16(24):6169-76. doi: 10.1158/1078-0432.CCR-10-0281.
Other Identifiers
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SWOG-8897-ICSC
Identifier Type: -
Identifier Source: secondary_id
CDR0000529126
Identifier Type: -
Identifier Source: org_study_id
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