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DNA Analysis in Predicting Treatment Outcome in Women With Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
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
History of Changes
  Purpose

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.


Condition Intervention
Breast Cancer
 Genetic: mutation analysis
Genetic: polymorphism analysis
Other: surface-enhanced laser desorption/ionization-time of flight mass spectrometry

Study Type: Observational
Official Title: Pharmacogenetics in Relation to Breast Cancer Outcomes in SWOG 8897

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Differences in outcome according to common variant alleles [ Designated as safety issue: No ]

Estimated Enrollment: 1577
Study Start Date: December 2006
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00896623

Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Christine B. Ambrosone, PhD Roswell Park Cancer Institute
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00896623     History of Changes
Other Study ID Numbers: CDR0000529126, SWOG-8897-ICSC
Study First Received: May 9, 2009
Last Updated: January 14, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 18, 2013