We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00898898
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : July 2, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Breast Cancer Other: diagnostic laboratory biomarker analysis

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 2837 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : May 2000
Actual Primary Completion Date : January 2010
Actual Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Biospecimen Retention:   Samples With DNA
Tissue (FFPE whole block sections and TMA sections)

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00898898


Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Study Chair: Edith A. Perez, MD Mayo Clinic
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00898898    
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) )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: July 2019
Keywords provided by Alliance for Clinical Trials in Oncology:
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
HER2-positive breast cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases