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:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00898898
First received: May 9, 2009
Last updated: February 1, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
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

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1649
Study Start Date: January 2008
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00898898

Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Edith A. Perez, MD Mayo Clinic
  More Information

Additional Information:
No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00898898     History of Changes
Other Study ID Numbers: CDR0000593349, NCCTG-N9831-ICSC
Study First Received: May 9, 2009
Last Updated: February 1, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014