Ignite Creation Date:
2024-05-05 @ 9:28 PM
Last Modification Date:
2024-10-26 @ 10:05 AM
Study NCT ID:
NCT00898898
Status:
COMPLETED
Last Update Posted:
2019-07-02
First Post:
2009-05-09
Brief Title:
Studying Tissue Samples From Women With Breast Cancer Who Were Treated on Clinical Trial NCCTG-N9831
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 expressionamplificationmutation 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 expressionamplificationmutation status and known clinicopathological characteristics of the tumors
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 expressionamplificationmutation 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 expressionamplificationmutation status and known clinicopathological characteristics of the tumors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2009-00687 | REGISTRY | CTRP Clinical Trials Reporting System | None |
| NCCTG-N9831-ICSC | None | None | None |
| CDR0000593349 | REGISTRY | None | None |