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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00896623
First received: May 9, 2009
Last updated: February 15, 2017
Last verified: February 2017

May 9, 2009
February 15, 2017
December 2006
June 2007   (Final data collection date for primary outcome measure)
Differences in outcome according to common variant alleles [ Time Frame: Through study follow-up an average of 10.8 years ]
Differences in outcome according to common variant alleles
Complete list of historical versions of study NCT00896623 on ClinicalTrials.gov Archive Site
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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

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.

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.

Observational
Observational Model: Other
Time Perspective: Retrospective
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Non-Probability Sample
patients enrolled to SWOG 8897 consenting to banking
Breast Cancer
  • Genetic: mutation analysis
  • Genetic: polymorphism analysis
  • Other: surface-enhanced laser desorption/ionization-time of flight mass spectrometry
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1577
June 2007
June 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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NCT00896623
CDR0000529126
SWOG-8897-ICSC
No
Not Provided
Yes
https://swog.org/Visitors/Download/Policies/Policy43.pdf
Southwest Oncology Group
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Christine B. Ambrosone, PhD Roswell Park Cancer Institute
Southwest Oncology Group
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP