NCT00898898

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

Analyses of c-Myc (MYC) and Topoisomerase II Alpha (TOP2A) Copy Number Aberrations; MYC, Insulin-like Growth Factor Receptor-1 (IGF-1R) and PTEN Protein Expressions; and Phosphatidylinositol 3' Kinase (PIK3) Gene Mutations in N9831 Primary Breast Tumors

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,837 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	diagnostic laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2000-05-01
• Primary completion: 2010-01-01
• Completion: 2019-04-01
• First posted: 2009-05-12
• Last updated: 2019-07-02