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:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00898898
First received: May 9, 2009
Last updated: July 23, 2015
Last verified: July 2015

May 9, 2009
July 23, 2015
May 2000
January 2100   (final data collection date for primary outcome measure)
  • Levels of primary breast tumor protein expression of MYC, IGF-1R, and PTEN assessed using standard immunohistochemical (IHC) procedures [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Levels of primary breast tumor amplification status of MYC and TOP2A assessed using standard fluorescence in situ hybridization (FISH) assays [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Levels of primary breast tumor mutation status of PIK3 assessed using molecular digestion followed by HPLC separation [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • the proportions of specimens with PIK3 mutations in both exons 9 and 20 [ 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 exon 9 [ Designated as safety issue: No ]
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

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

Tissue (FFPE whole block sections and TMA sections)

Non-Probability Sample

Female patients with primary HER2 positive breast cancer which received doxorubicin and cyclophosphamide (AC) followed by paclitaxel with or without trastuzumab.

Breast Cancer
Other: diagnostic laboratory biomarker analysis
Correlative studies
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.
Intervention: Other: diagnostic laboratory biomarker analysis
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1649
Not Provided
January 2100   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00898898
NCCTG N9831-ICSC, NCCTG-N9831-ICSC, CDR0000593349, NCI-2009-00687
Yes
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Edith A. Perez, MD Mayo Clinic
Alliance for Clinical Trials in Oncology
July 2015

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