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

Sponsor:	North Central Cancer Treatment Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00898898

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:

Genetics Home Reference related topics: breast cancer Help Me Understand Genetics

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

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

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

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Edith A. Perez, MD

Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000593349, NCCTG-N9831-ICSC
Study First Received:	May 9, 2009
Last Updated:	June 9, 2009
ClinicalTrials.gov Identifier:	NCT00898898 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
HER2-positive breast cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on February 08, 2010