Studying Tissue Samples From Women With Breast Cancer Who Were Treated on Clinical Trial NCCTG-N9831
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|ClinicalTrials.gov Identifier: NCT00898898|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : July 2, 2019
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|Condition or disease||Intervention/treatment|
|Breast Cancer||Other: diagnostic laboratory biomarker analysis|
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.
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.
|Study Type :||Observational|
|Actual Enrollment :||2837 participants|
|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|
|Actual Study Start Date :||May 2000|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||April 2019|
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.
Other: diagnostic laboratory biomarker analysis
- 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 ]
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00898898
|Study Chair:||Edith A. Perez, MD||Mayo Clinic|
|Responsible Party:||Alliance for Clinical Trials in Oncology|
|Other Study ID Numbers:||
CDR0000593349 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2009-00687 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
|First Posted:||May 12, 2009 Key Record Dates|
|Last Update Posted:||July 2, 2019|
|Last Verified:||July 2019|
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
HER2-positive breast cancer
Neoplasms by Site