SWOG 8897-A DNA Analysis in Predicting Treatment Outcome in Women With Breast Cancer in SWOG 8897

Pharmacogenetics in Relation to Breast Cancer Outcomes in SWOG 8897

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00896623

Enrollment

1577

Registered

2009-05-12

Start date

2006-12-31

Completion date

2007-06-30

Last updated

2017-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

stage I breast cancer, stage II breast cancer

Brief summary

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict a patient's response to treatment. PURPOSE: This laboratory study is looking at DNA in tissue samples from women with breast cancer to see if it can predict treatment outcome.

Detailed description

OBJECTIVES: * 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.

Interventions

GENETICmutation analysis

GENETICpolymorphism analysis

OTHERsurface-enhanced laser desorption/ionization-time of flight mass spectrometry

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * 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

Design outcomes

Primary

Measure	Time frame
Differences in outcome according to common variant alleles	Through study follow-up an average of 10.8 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026