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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.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group Identifier:
First received: May 9, 2009
Last updated: February 15, 2017
Last verified: February 2017

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
Study Design: Observational Model: Other
Time Perspective: Retrospective
Official Title: Pharmacogenetics in Relation to Breast Cancer Outcomes in SWOG 8897

Resource links provided by NLM:

Further study details as provided by Southwest Oncology Group:

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

Enrollment: 1577
Study Start Date: December 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00896623

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

Responsible Party: Southwest Oncology Group Identifier: NCT00896623     History of Changes
Other Study ID Numbers: CDR0000529126
Study First Received: May 9, 2009
Last Updated: February 15, 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 processed this record on September 21, 2017