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

This study has been completed.
Sponsor:
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:
NCT01423890
First received: August 24, 2011
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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 Intervention
Breast Cancer
Genetic: ONCOTYPEDX Test

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Prospective Cohort Study to Evaluate the Oncotype DX® Test in Early Stage Breast Cancer

Resource links provided by NLM:


Further study details as provided by Ontario Clinical Oncology Group (OCOG):

Primary Outcome Measures:
  • Change in treatment recommendation [ Time Frame: One month ] [ Designated as safety issue: No ]
    The primary outcome is the change in treatment recommendation by the oncologist and the change in treatment preference of the patient.


Secondary Outcome Measures:
  • Association between Oncotype DX® RS with other estimated risk calculations [ Time Frame: One month ] [ Designated as safety issue: No ]
    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.

  • Change in patient decisional conflict [ Time Frame: One month ] [ Designated as safety issue: No ]
    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.

  • Robustness of economic model of sequential Adjuvant! Online followed by Oncotype DX®. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To determine the robustness of the economic model of sequential Adjuvant! Online followed by Oncotype DX®.


Enrollment: 1011
Study Start Date: January 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01423890

Locations
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
The Scarborough Hospital
Scarborough, Ontario, Canada, M1P 2T7
Rouge Valley Health System
Scarborough, Ontario, Canada, M1E 5E9
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
Toronto East General Hospital
Toronto, Ontario, Canada, M4C 3E7
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sunnybrook Health Sciences - Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
St. Joseph's Healthcare
Toronto, Ontario, Canada, M6R 1B5
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
North York General Hospital
Toronto, Ontario, Canada, M2K 1E1
Humber River Regional Cancer Centre
Toronto, Ontario, Canada, M9N 1N8
Trillium Health Centre
Toronto, Ontario, Canada, M9C 1A5
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
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
Investigators
Principal Investigator: Mark N. Levine, MD Ontario Clinical Oncology Group (OCOG)
  More Information

No publications provided

Responsible Party: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier: NCT01423890     History of Changes
Other Study ID Numbers: OCOG-2011-ONCOTYPEDX
Study First Received: August 24, 2011
Last Updated: March 26, 2014
Health Authority: Canada: Ministry of Health & Long Term Care, Ontario

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
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014