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

SWOG Cancer Research Network

Status: Completed

Conditions: Breast Cancer

Treatments: Genetic: mutation analysis; Other: surface-enhanced laser desorption/ionization-time of flight mass spectrometry; Genetic: polymorphism analysis

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT00896623

CDR0000529126

SWOG-8897-ICSC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,577 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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