Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment diagnostic laboratory biomarker analysis
Sponsor Alliance for Clinical Trials in Oncology
Collaborator National Cancer Institute (NCI)
Start date May 2000
End date January 2100
Trial size 1649 participants
Trial identifier NCT00898898, CDR0000593349, NCCTG N9831-ICSC, NCCTG-N9831-ICSC, NCI-2009-00687

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.

United States Minnesota
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
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.
diagnostic laboratory biomarker analysis
Correlative studies

Primary Outcomes

Measure
Levels of primary breast tumor protein expression of MYC, IGF-1R, and PTEN assessed using standard immunohistochemical (IHC) procedures
time frame: Baseline
Levels of primary breast tumor amplification status of MYC and TOP2A assessed using standard fluorescence in situ hybridization (FISH) assays
time frame: Baseline
Levels of primary breast tumor mutation status of PIK3 assessed using molecular digestion followed by HPLC separation
time frame: Baseline

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title 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
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology.