NCT01424865

Brief Summary

RATIONALE: 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. PURPOSE: This research trial studies biomarkers as a predictor of response to trastuzumab in samples from patients with breast cancer previously treated in the NSABP-B-31 trial.

Trial Health

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Trial Health Score

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

Enrollment
1,874

participants targeted

Target at P75+ for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

May 8, 2015

Status Verified

May 1, 2015

Enrollment Period

4.1 years

First QC Date

August 26, 2011

Last Update Submit

May 6, 2015

Conditions

Breast Cancer

Keywords

HER2-positive breast cancerstage II breast cancerstage IIIA breast cancer

Outcome Measures

Primary Outcomes (1)

  • ALDH1 expression (percentage of stem cells within the tumor) and association with outcomes regardless of HER2 staining

    approximately 4 years

Secondary Outcomes (1)

  • HER2 expression in cells with stem cell-like properties as a determinant of aggressiveness and response to trastuzumab in the adjuvant setting

    approximately 4 years

Interventions

fluorescence in situ hybridizationGENETIC
immunohistochemistry staining methodOTHER
immunologic techniqueOTHER
laboratory biomarker analysisOTHER

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary cancer tissue from participants in protocol NSABP B-31.

DISEASE CHARACTERISTICS: * Tissue samples from patients with node-positive breast cancer whose tumors overexpress HER2 * Primary tumor samples that are negative for HER2 using classically accepted cutoffs determined in the metastatic setting * Treated with adjuvant therapy comprising doxorubicin hydrochloride, cyclophosphamide, and paclitaxel with or without trastuzumab in the NSABP-B-31 trial PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

In Situ Hybridization, FluorescenceImmunohistochemistryImmunologic Techniques

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

In Situ HybridizationStaining and LabelingHistocytological Preparation TechniquesCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesCytogenetic AnalysisGenetic TechniquesNucleic Acid HybridizationHistocytochemistry

Study Officials

  • Daniel F. Hayes, MD

    University of Michigan Rogel Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2011

First Posted

August 29, 2011

Study Start

November 1, 2011

Primary Completion

December 1, 2015

Last Updated

May 8, 2015

Record last verified: 2015-05