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

March 26, 2014 updated by: Ontario Clinical Oncology Group (OCOG)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The evidence supporting the adoption of Oncotype DX® is relatively weak by the criteria used by the Ontario Health Technology Advisory Committee (OHTAC). There is only one small published prospective study that reports on Oncotype DX® changing clinical management. The economic models that estimated the potential advantages of using an Oncotype DX® guided treatment strategy may have overestimated the benefits because they assumed that all patients with tumors >1cm in the absence of Oncotype DX® testing would receive chemotherapy in addition to tamoxifen, and that the magnitude of benefit with chemotherapy over tamoxifen is relatively large, i.e. reduces recurrence risk by 74% and associated with an absolute benefit of 28%. (The benefit comes from one trial and is applied to all patients). It is estimated that there are about 3,300 incident cases with node negative, ER positive, HER2 neu negative tumors annually in Ontario, it is important to evaluate the adoption of this test for decision making in Ontario.

Study Type

Interventional

Enrollment (Actual)

1011

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Simcoe Muskoka Cancer Program - Royal Victoria Hospital
      • Belleville, Ontario, Canada, K8N 5A9
        • Quinte Healthcare Corporation
      • Brampton, Ontario, Canada, L6R 3J7
        • William Osler Health Centre
      • Brantford, Ontario, Canada, N3R 1G9
        • Brantford General Hospital
      • Burlington, Ontario, Canada, L7S 1W7
        • Joseph Brant Hospital
      • Cambridge, Ontario, Canada, N1R 3G2
        • Cambridge Memorial Hospital
      • Hamilton, Ontario, Canada, L8V 1C3
        • Juravinski Cancer Centre
      • Kingston, Ontario, Canada, K7L 5P9
        • Cancer Centre of Southeastern Ontario at Kingston
      • Kitchener, Ontario, Canada, N2G 1G3
        • Grand River Regional Cancer Centre
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Centre
      • Markham, Ontario, Canada, L6B 1A1
        • Markham Stouffville Hospital
      • Mississauga, Ontario, Canada, L5M 2N1
        • The Credit Valley Hospital
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Stronach Regional Cancer Centre
      • Oshawa, Ontario, Canada, L1G 2B9
        • R.S. McLaughlin Durham Regional Cancer Centre - Lakeridge Health
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital Regional Cancer Centre
      • Owen Sound, Ontario, Canada, N4K 6M9
        • Grey Bruce Health Services
      • Peterborough, Ontario, Canada, K9J 7C6
        • Peterborough Regional Health Centre
      • Richmond Hill, Ontario, Canada, L4C 4Z3
        • Mackenzie Health
      • Sarnia, Ontario, Canada, N7T 6S3
        • Bluewater Health
      • Sault Ste. Marie, Ontario, Canada, P6B 0A8
        • Algoma District Cancer Program - Sault Area Hospital
      • Scarborough, Ontario, Canada, M1P 2T7
        • The Scarborough Hospital
      • Scarborough, Ontario, Canada, M1E 5E9
        • Rouge Valley Health System
      • St. Catharines, Ontario, Canada, L2R 7C6
        • Niagara Health System
      • Sudbury, Ontario, Canada, P3E 5J1
        • Northeast Cancer Centre of Health Sciences North - Horizon Sante-Nord
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • Thunder Bay Regional Health Sciences Centre
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
      • Toronto, Ontario, Canada, M4C 3E7
        • Toronto East General Hospital
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital
      • Toronto, Ontario, Canada, M2K 1E1
        • North York General Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences - Odette Cancer Centre
      • Toronto, Ontario, Canada, M6R 1B5
        • St. Joseph's Healthcare
      • Toronto, Ontario, Canada, M9C 1A5
        • Trillium Health Centre
      • Toronto, Ontario, Canada, M9N 1N8
        • Humber River Regional Cancer Centre
      • Windsor, Ontario, Canada, N8W 2X3
        • Windsor Regional Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Women or men with histologic evidence of invasive breast cancer (ductal, lobular or mixed disease).
  • Surgical resection including breast conserving surgery or modified radical mastectomy or simple mastectomy, within the last four months.

  • Axillary lymph nodes assessed for tumor by:

    (i) sentinel node biopsy, or (ii) axillary node dissection, or (iii) both

  • Axillary lymph node assessment negative for cancer, or positive only for micrometastases (i.e., cancer <2mm by H&E stain).
  • Tumor is estrogen receptor (ER) positive.
  • Receiving or to receive adjuvant endocrine therapy (i.e., tamoxifen or aromatase inhibitor).
  • Being considered for adjuvant chemotherapy.

Exclusion Criteria:

  • Axillary lymph node positive for cancer.
  • Patients with inoperable locally advanced breast cancer.
  • Metastatic breast cancer, including local ipsilateral recurrence.
  • HER2 neu positive.
  • Physician/Patient unwilling to comply with study protocol.
  • Inability to provide informed consent (e.g. dementia or severe cognitive impairment).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Early Stage Breast Cancer
Women and men with node negative, ER positive breast cancer who are receiving (or will receive) endocrine therapy, and who are candidates for chemotherapy.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in treatment recommendation
Time Frame: One month
The primary outcome is the change in treatment recommendation by the oncologist and the change in treatment preference of the patient.
One month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between Oncotype DX® RS with other estimated risk calculations
Time Frame: One month
The level of association between the Oncotype DX® RS with estimated recurrence risk calculated by Adjuvant! Online, as well as with traditional factors including tumor size, grade, and HER2 neu.
One month
Change in patient decisional conflict
Time Frame: One month
The change in the level of patient decisional conflict measured by the Decisional Conflict Scale (DCS). Additionally, the DCS has three subscales: uncertainty, effective decision making, and factors contributing to uncertainty. The change in each of these subscales will also be measured.
One month
Robustness of economic model of sequential Adjuvant! Online followed by Oncotype DX®.
Time Frame: 6 months
To determine the robustness of the economic model of sequential Adjuvant! Online followed by Oncotype DX®.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ontario Clinical Oncology Group (OCOG)

Collaborators

Ontario Ministry of Health and Long Term Care

Investigators

  • Principal Investigator: Mark N. Levine, MD, Ontario Clinical Oncology Group (OCOG)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

August 24, 2011

First Submitted That Met QC Criteria

August 24, 2011

First Posted (Estimate)

August 26, 2011

Study Record Updates

Last Update Posted (Estimate)

March 27, 2014

Last Update Submitted That Met QC Criteria

March 26, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCOG-2011-ONCOTYPEDX

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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