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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00898898

Enrollment

2837

Registered

2009-05-12

Start date

2000-05-31

Completion date

2019-04-30

Last updated

2019-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, HER2-positive breast cancer

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.

Interventions

OTHERdiagnostic laboratory biomarker analysis

Correlative studies

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Levels of primary breast tumor protein expression of MYC, IGF-1R, and PTEN assessed using standard immunohistochemical (IHC) procedures	Baseline
Levels of primary breast tumor amplification status of MYC and TOP2A assessed using standard fluorescence in situ hybridization (FISH) assays	Baseline
Levels of primary breast tumor mutation status of PIK3 assessed using molecular digestion followed by HPLC separation	Baseline

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026