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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00896623
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : February 17, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

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.

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

Detailed Description:


  • 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.

Study Type : Observational
Actual Enrollment : 1577 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Pharmacogenetics in Relation to Breast Cancer Outcomes in SWOG 8897
Study Start Date : December 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. Differences in outcome according to common variant alleles [ Time Frame: Through study follow-up an average of 10.8 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients enrolled to SWOG 8897 consenting to banking


  • 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


  • Female
  • Pre- or post-menopausal


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00896623

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

Publications of Results:
Responsible Party: Southwest Oncology Group Identifier: NCT00896623     History of Changes
Other Study ID Numbers: CDR0000529126
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Keywords provided by Southwest Oncology Group:
stage I breast cancer
stage II breast cancer

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