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| ID | Type | Description | Link |
|---|---|---|---|
| NCCTG-N9831-ICSC | |||
| CDR0000593349 | Registry Identifier | PDQ (Physician Data Query) | |
| NCI-2009-00687 | Registry Identifier | CTRP (Clinical Trials Reporting System) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diagnostic laboratory biomarker analysis | Other | Correlative studies |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 amplification status of MYC and TOP2A assessed using standard fluorescence in situ hybridization (FISH) assays | Baseline | |
| Levels of primary breast tumor mutation status of PIK3 assessed using molecular digestion followed by HPLC separation | Baseline |
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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
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Female patients with primary HER2 positive breast cancer which received doxorubicin and cyclophosphamide (AC) followed by paclitaxel with or without trastuzumab.
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| Name | Affiliation | Role |
|---|---|---|
| Edith A. Perez, MD | Mayo Clinic | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21245420 | Derived | Perez EA, Jenkins RB, Dueck AC, Wiktor AE, Bedroske PP, Anderson SK, Ketterling RP, Sukov WR, Kanehira K, Chen B, Geiger XJ, Andorfer CA, McCullough AE, Davidson NE, Martino S, Sledge GW, Kaufman PA, Kutteh LA, Gralow JR, Harris LN, Ingle JN, Lingle WL, Reinholz MM. C-MYC alterations and association with patient outcome in early-stage HER2-positive breast cancer from the north central cancer treatment group N9831 adjuvant trastuzumab trial. J Clin Oncol. 2011 Feb 20;29(6):651-9. doi: 10.1200/JCO.2010.30.2125. Epub 2011 Jan 18. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Tissue (FFPE whole block sections and TMA sections)
| D017437 |
| Skin and Connective Tissue Diseases |