DNA Analysis in Predicting Treatment Outcome in Women With Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00896623
First received: May 9, 2009
Last updated: January 14, 2011
Last verified: June 2007

May 9, 2009
January 14, 2011
December 2006
Not Provided
Differences in outcome according to common variant alleles [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00896623 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
DNA Analysis in Predicting Treatment Outcome in Women With Breast Cancer
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
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
Breast Cancer
  • Genetic: mutation analysis
  • Genetic: polymorphism analysis
  • Other: surface-enhanced laser desorption/ionization-time of flight mass spectrometry
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1577
Not Provided
Not Provided

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00896623
CDR0000529126, SWOG-8897-ICSC
Not Provided
Not Provided
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Christine B. Ambrosone, PhD Roswell Park Cancer Institute
National Cancer Institute (NCI)
June 2007

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