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

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ClinicalTrials.gov Identifier: NCT00898898
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : July 2, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date May 9, 2009
First Posted Date May 12, 2009
Last Update Posted Date July 2, 2019
Actual Study Start Date May 2000
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 21, 2015)
  • 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 ]
Original Primary Outcome Measures
 (submitted: May 9, 2009)
  • The proportions of specimens with PIK3 mutations in exon 9
  • the proportions of specimens with PIK3 mutations in exon 20
  • the proportions of specimens with PIK3 mutations in both exons 9 and 20
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Studying Tissue Samples From Women With Breast Cancer Who Were Treated on Clinical Trial NCCTG-N9831
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
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 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Tissue (FFPE whole block sections and TMA sections)
Sampling Method Non-Probability Sample
Study Population Female patients with primary HER2 positive breast cancer which received doxorubicin and cyclophosphamide (AC) followed by paclitaxel with or without trastuzumab.
Condition Breast Cancer
Intervention Other: diagnostic laboratory biomarker analysis
Correlative studies
Study Groups/Cohorts 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
Publications * 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.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 1, 2019)
2837
Original Estimated Enrollment
 (submitted: May 9, 2009)
1649
Actual Study Completion Date April 2019
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00898898
Other Study ID Numbers NCCTG N9831-ICSC
NCCTG-N9831-ICSC
CDR0000593349 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2009-00687 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor Alliance for Clinical Trials in Oncology
Collaborators National Cancer Institute (NCI)
Investigators
Study Chair: Edith A. Perez, MD Mayo Clinic
PRS Account Alliance for Clinical Trials in Oncology
Verification Date July 2019