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

Breast Cancer Clinical Trial

Official title:

Pharmacogenetics in Relation to Breast Cancer Outcomes in SWOG 8897

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00896623
• Other study ID #: CDR0000529126
• Secondary ID: SWOG-8897-ICSC
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: February 15, 2017
• Start date: December 2006
• Est. completion date: June 2007

Study information

• Verified date: February 2017
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1577
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Genetic:
• mutation analysis

• polymorphism analysis

Other:
• surface-enhanced laser desorption/ionization-time of flight mass spectrometry

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

References & Publications (2)

Yao S, Barlow WE, Albain KS, Choi JY, Zhao H, Livingston RB, Davis W, Rae JM, Yeh IT, Hutchins LF, Ravdin PM, Martino S, Lyss AP, Osborne CK, Abeloff M, Hortobagyi GN, Hayes DF, Ambrosone CB. Gene polymorphisms in cyclophosphamide metabolism pathway,treat — View Citation

Yao S, Barlow WE, Albain KS, Choi JY, Zhao H, Livingston RB, Davis W, Rae JM, Yeh IT, Hutchins LF, Ravdin PM, Martino S, Lyss AP, Osborne CK, Abeloff MD, Hortobagyi GN, Hayes DF, Ambrosone CB. Manganese superoxide dismutase polymorphism, treatment-related — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in outcome according to common variant alleles		Through study follow-up an average of 10.8 years

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database