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

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Completed
CT.gov ID
NCT00898898
Collaborator
National Cancer Institute (NCI) (NIH)
2,837
Enrollment
227
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: diagnostic laboratory biomarker analysis

Detailed Description

PRIMARY OBJECTIVES:

  1. 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.

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

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

SECONDARY OBJECTIVES:

  1. 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.

  2. To investigate the predictive potential of multiple marker analyses on DFS and overall survival using multivariate analysis.

  3. To determine the correlation between the protein expression and amplification status of MYC in patients randomized on NCCTG-N9831.

  4. To determine the correlation between marker protein expression/amplification/mutation status and known clinicopathological characteristics of the tumors.

Study Design

Study Type:
Observational
Actual Enrollment :
2837 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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
Actual Study Start Date :
May 1, 2000
Actual Primary Completion Date :
Jan 1, 2010
Actual Study Completion Date :
Apr 1, 2019

Arms and Interventions

Arm Intervention/Treatment
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.

Other: diagnostic laboratory biomarker analysis
Correlative studies

Outcome Measures

Primary Outcome Measures

  1. Levels of primary breast tumor protein expression of MYC, IGF-1R, and PTEN assessed using standard immunohistochemical (IHC) procedures [Baseline]

  2. Levels of primary breast tumor amplification status of MYC and TOP2A assessed using standard fluorescence in situ hybridization (FISH) assays [Baseline]

  3. Levels of primary breast tumor mutation status of PIK3 assessed using molecular digestion followed by HPLC separation [Baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Alliance for Clinical Trials in Oncology
  • National Cancer Institute (NCI)

Investigators

  • Study Chair: Edith A. Perez, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00898898
Other Study ID Numbers:
  • NCCTG N9831-ICSC
  • NCCTG-N9831-ICSC
  • CDR0000593349
  • NCI-2009-00687
First Posted:
May 12, 2009
Last Update Posted:
Jul 2, 2019
Last Verified:
Jul 1, 2019
Keywords provided by Alliance for Clinical Trials in Oncology
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
HER2-positive breast cancer
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Jul 2, 2019