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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:
ClinicalTrials.gov Identifier:
NCT00896623
First Posted: May 12, 2009
Last Update Posted: February 17, 2017
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
  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
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:

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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
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 ClinicalTrials.gov identifier (NCT number): NCT00896623


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

Publications:
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00896623     History of Changes
Other Study ID Numbers: CDR0000529126
SWOG-8897-ICSC
First Submitted: May 9, 2009
First Posted: May 12, 2009
Last Update Posted: February 17, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: https://swog.org/Visitors/Download/Policies/Policy43.pdf

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

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