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The Impact of the Oncotype DX® Breast Cancer Assay on Treatment Decisions in a Canadian Population

NCT02347449 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-10-23

No results posted yet for this study

Summary

The main goal of this study is to characterize whether the results of the Oncotype DX® assay affect the physician's treatment recommendations for the adjuvant treatment of women with ER-positive (ER+), early breast cancer (EBC) with 1-3 positive lymph nodes who are potential candidates for chemotherapy, but for whom the benefits of chemotherapy may be uncertain.

Conditions

  • Hormone Receptor Positive Malignant Neoplasm of Breast

Interventions

OTHER

Questionnaires, Oncotype Dx Assay

1. Physician pre-assay questionnaire 2. Patient pre-assay questionnaire 3. Oncotype DX® Assay 4. Physician post- assay questionnaire 5. Patient post-assay questionnaire

Sponsors & Collaborators

  • Genomic Health®, Inc.

    collaborator INDUSTRY

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Andrea Eisen, MD · Sunnybrook Health Sciences Centre

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • Canada

Study Locations

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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 NCT02347449 on ClinicalTrials.gov