SWOG 8897-A DNA Analysis in Predicting Treatment Outcome in Women With Breast Cancer in SWOG 8897
|ClinicalTrials.gov Identifier: NCT00896623|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : February 17, 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 or disease||Intervention/treatment|
|Breast Cancer||Genetic: mutation analysis Genetic: polymorphism analysis Other: surface-enhanced laser desorption/ionization-time of flight mass spectrometry|
- 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|
|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|
- Differences in outcome according to common variant alleles [ Time Frame: Through study follow-up an average of 10.8 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00896623
|Study Chair:||Christine B. Ambrosone, PhD||Roswell Park Cancer Institute|