Studying Tissue Samples From Women With Breast Cancer Who Were Treated on Clinical Trial NCCTG-N9831
- Conditions
- Breast Cancer
- Interventions
- Other: diagnostic laboratory biomarker analysis
- Registration Number
- NCT00898898
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 2837
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Arm I diagnostic laboratory biomarker analysis 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.
- Primary Outcome Measures
Name Time Method Levels of primary breast tumor protein expression of MYC, IGF-1R, and PTEN assessed using standard immunohistochemical (IHC) procedures Baseline Levels of primary breast tumor mutation status of PIK3 assessed using molecular digestion followed by HPLC separation Baseline Levels of primary breast tumor amplification status of MYC and TOP2A assessed using standard fluorescence in situ hybridization (FISH) assays Baseline
- Secondary Outcome Measures
Name Time Method