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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

diagnostic laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start: 2000
Primary completion: 2010
Study completion: 2019
First posted: May 12, 2009
Registry last updated: Jul 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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