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A Prospective Cohort Study to Evaluate the Oncotype DX® Test in Early Stage Breast Cancer

NCT01423890 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1011

Last updated 2014-03-27

No results posted yet for this study

Summary

A prospective population-based cohort study is being conducted in Ontario to evaluate whether the performance of Oncotype DX® changes the treatment recommended and the treatment received in women or men with node negative, ER positive breast cancer who are receiving (or will receive) endocrine therapy and who are candidates for chemotherapy. One thousand eligible consenting women and men will have their tumor tissue specimen sent to Genomic Health where the Oncotype DX® assay will be performed.

Conditions

Interventions

GENETIC

ONCOTYPEDX Test

Gene signature test containing 21 genes (16 cancer-related genes, e.g., invasion, proliferation, ER, Her 2 and five reference genes) and generates an individualized recurrence score.

Sponsors & Collaborators

  • Ontario Ministry of Health and Long Term Care

    collaborator OTHER_GOV

  • Ontario Clinical Oncology Group (OCOG)

    lead OTHER

Principal Investigators

  • Mark N. Levine, MD · Ontario Clinical Oncology Group (OCOG)

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01423890 on ClinicalTrials.gov