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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01423890
Recruitment Status : Completed
First Posted : August 26, 2011
Last Update Posted : March 27, 2014
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Genetic: ONCOTYPEDX Test Not Applicable

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  (Clinical Trial)
Actual Enrollment : 1011 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Prospective Cohort Study to Evaluate the Oncotype DX® Test in Early Stage Breast Cancer
Study Start Date : January 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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®.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01423890

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

Responsible Party: Ontario Clinical Oncology Group (OCOG) Identifier: NCT01423890     History of Changes
Other Study ID Numbers: OCOG-2011-ONCOTYPEDX
First Posted: August 26, 2011    Key Record Dates
Last Update Posted: March 27, 2014
Last Verified: March 2014

Keywords provided by Ontario Clinical Oncology Group (OCOG):
Breast Cancer
Oncotype DX
Adjuvant! Online
Decisional Conflict Scale

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases