NCT00898898

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,837

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2000

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2000

Completed
9 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
9.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

July 2, 2019

Status Verified

July 1, 2019

Enrollment Period

9.7 years

First QC Date

May 9, 2009

Last Update Submit

July 1, 2019

Conditions

Breast Cancer

Keywords

stage IA breast cancerstage IB breast cancerstage II breast cancerstage IIIA breast cancerHER2-positive breast cancer

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

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

Interventions

diagnostic laboratory biomarker analysisOTHER

Correlative studies

Arm I

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Perez EA, Jenkins RB, Dueck AC, Wiktor AE, Bedroske PP, Anderson SK, Ketterling RP, Sukov WR, Kanehira K, Chen B, Geiger XJ, Andorfer CA, McCullough AE, Davidson NE, Martino S, Sledge GW, Kaufman PA, Kutteh LA, Gralow JR, Harris LN, Ingle JN, Lingle WL, Reinholz MM. C-MYC alterations and association with patient outcome in early-stage HER2-positive breast cancer from the north central cancer treatment group N9831 adjuvant trastuzumab trial. J Clin Oncol. 2011 Feb 20;29(6):651-9. doi: 10.1200/JCO.2010.30.2125. Epub 2011 Jan 18.

    PMID: 21245420DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Tissue (FFPE whole block sections and TMA sections)

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Edith A. Perez, MD

    Mayo Clinic

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

May 1, 2000

Primary Completion

January 1, 2010

Study Completion

April 1, 2019

Last Updated

July 2, 2019

Record last verified: 2019-07