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

July 1, 2019 updated by: Alliance for Clinical Trials in Oncology

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Observational

Enrollment (Actual)

2837

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Female patients with primary HER2 positive breast cancer which received doxorubicin and cyclophosphamide (AC) followed by paclitaxel with or without trastuzumab.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2000

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Actual)

July 2, 2019

Last Update Submitted That Met QC Criteria

July 1, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCTG N9831-ICSC
  • NCCTG-N9831-ICSC
  • CDR0000593349 (Registry Identifier: PDQ (Physician Data Query))
  • NCI-2009-00687 (Registry Identifier: CTRP (Clinical Trials Reporting System))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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