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Studying Tissue Samples From Women With Breast Cancer Who Were Treated on Clinical Trial NCCTG-N9831

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00898898
First received: May 9, 2009
Last updated: February 1, 2013
Last verified: January 2013
History of Changes

May 9, 2009
February 1, 2013
January 2008
October 2013   (final data collection date for primary outcome measure)
  • The proportions of specimens with PIK3 mutations in exon 9 [ Designated as safety issue: No ]
  • the proportions of specimens with PIK3 mutations in exon 20 [ Designated as safety issue: No ]
  • the proportions of specimens with PIK3 mutations in both exons 9 and 20 [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00898898 on ClinicalTrials.gov Archive Site
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Studying Tissue Samples From Women With Breast Cancer Who Were Treated on Clinical Trial NCCTG-N9831
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

RATIONALE: 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.

PURPOSE: This research study is looking at tissue samples from women with breast cancer who were treated on clinical trial NCCTG-N9831.

OBJECTIVES:

Primary

  • 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.
  • To determine the association between the primary breast tumor amplification status of MYC and TOP2A and DFS in patients randomized on NCCTG-N9831.
  • To determine the association between the primary breast tumor mutation status of PIK3 and DFS in patients randomized on NCCTG-N9831.

Secondary

  • 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.
  • To investigate the predictive potential of multiple marker analyses on DFS and overall survival using multivariate analysis.
  • To determine the correlation between the protein expression and amplification status of MYC in patients randomized on NCCTG-N9831.
  • To determine the correlation between marker protein expression/amplification/mutation status and known clinicopathological characteristics of the tumors.

OUTLINE: This is a multicenter study.

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.
Observational
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Breast Cancer
  • Genetic: fluorescence in situ hybridization
  • Genetic: mutation analysis
  • Genetic: polymerase chain reaction
  • Genetic: protein expression analysis
  • Other: immunohistochemistry staining method
  • Other: laboratory biomarker analysis
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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 Jan 18; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1649
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October 2013   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • Any menopausal status

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00898898
CDR0000593349, NCCTG-N9831-ICSC
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North Central Cancer Treatment Group
National Cancer Institute (NCI)
Study Chair: Edith A. Perez, MD Mayo Clinic
National Cancer Institute (NCI)
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP