Studying Tissue Samples From Women With Breast Cancer Who Were Treated on Clinical Trial NCCTG-N9831

Alliance for Clinical Trials in Oncology

Status: Completed

Conditions: Breast Cancer

Treatments: Other: diagnostic laboratory biomarker analysis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00898898

CDR0000593349 (Registry Identifier)

NCI-2009-00687 (Registry Identifier)

NCCTG N9831-ICSC

NCCTG-N9831-ICSC

Details and patient eligibility

About

This research study is looking at tissue samples from women with breast cancer who were treated on clinical trial NCCTG-N9831. 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 how patients will respond to treatment.

Full description

PRIMARY OBJECTIVES:

I. To determine the association between the primary breast tumor protein expression of MYC, IGF-1R, and PTEN and disease-free survival (DFS) in patients randomized on clinical trial NCCTG-N9831.

II. To determine the association between the primary breast tumor amplification status of MYC and TOP2A and DFS in patients randomized on NCCTG-N9831.

III. To determine the association between the primary breast tumor mutation status of PIK3 and DFS in patients randomized on NCCTG-N9831.

SECONDARY OBJECTIVES:

I. To determine the association between the primary breast tumor marker protein expression/amplification/mutation status of the aforementioned markers and overall survival in patients randomized on NCCTG-N9831.

II. To investigate the predictive potential of multiple marker analyses on DFS and overall survival using multivariate analysis.

III. To determine the correlation between the protein expression and amplification status of MYC in patients randomized on NCCTG-N9831.

IV. To determine the correlation between marker protein expression/amplification/mutation status and known clinicopathological characteristics of the tumors.

Enrollment: 2,837 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Diagnosed with breast cancer and treated on clinical trial NCCTG-N9831

  * Randomized to treatment

• HER-2 positive disease

• Whole tissue blocks and/or tissue microarray sections available

• Hormone receptor status:

  * ER/PR status known

• Any menopausal status

Trial design

2,837 participants in 1 patient group

Arm I

Description:

Tissue samples from protocol NCCTG-N9831 are obtained for immunohistochemistry and fluorescence in situ hybridization analysis of MYC, IGF- 1R, PTEN, and TOP2A genes. Exons 9 and 20 of PIK3CA gene are amplified via polymerase chain reaction; mutations in exons 9 and 20 of PIK3CA gene are identified.

Treatment:

Other: diagnostic laboratory biomarker analysis