An observational study in Breast Cancer, sponsored by Alliance for Clinical Trials in Oncology. Completed. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-02.
Sponsored by Alliance for Clinical Trials in Oncology · Observational
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.
12,820 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 2,837 is above the median of 184 across 2,711 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Alliance for Clinical Trials in Oncology is the lead sponsor of 509 studies on the registry; 28 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Female patients with primary HER2 positive breast cancer which received doxorubicin and cyclophosphamide (AC) followed by paclitaxel with or without trastuzumab.
Inclusion Criteria
Diagnosed with breast cancer and treated on clinical trial NCCTG-N9831
* Randomized to treatment
Hormone receptor status:
* ER/PR status known
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
Correlative studies
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
No study locations are listed for this record.
Ran from May 2000 to primary completion in Jan 2010, 116 months.
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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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