A Prospective Cohort Study to Evaluate the Oncotype DX® Test in Early Stage Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Genetic: ONCOTYPEDX Test
- Registration Number
- NCT01423890
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1011
-
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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Early Stage Breast Cancer ONCOTYPEDX Test Women and men with node negative, ER positive breast cancer who are receiving (or will receive) endocrine therapy, and who are candidates for chemotherapy.
- Primary Outcome Measures
Name Time Method Change in treatment recommendation 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
Name Time Method Association between Oncotype DX® RS with other estimated risk calculations 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.
Change in patient decisional conflict 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.
Robustness of economic model of sequential Adjuvant! Online followed by Oncotype DX®. 6 months To determine the robustness of the economic model of sequential Adjuvant! Online followed by Oncotype DX®.
Trial Locations
- Locations (35)
William Osler Health Centre
🇨🇦Brampton, Ontario, Canada
Joseph Brant Hospital
🇨🇦Burlington, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston
🇨🇦Kingston, Ontario, Canada
Simcoe Muskoka Cancer Program - Royal Victoria Hospital
🇨🇦Barrie, Ontario, Canada
Cambridge Memorial Hospital
🇨🇦Cambridge, Ontario, Canada
Quinte Healthcare Corporation
🇨🇦Belleville, Ontario, Canada
R.S. McLaughlin Durham Regional Cancer Centre - Lakeridge Health
🇨🇦Oshawa, Ontario, Canada
Algoma District Cancer Program - Sault Area Hospital
🇨🇦Sault Ste. Marie, Ontario, Canada
Rouge Valley Health System
🇨🇦Scarborough, Ontario, Canada
Thunder Bay Regional Health Sciences Centre
🇨🇦Thunder Bay, Ontario, Canada
Northeast Cancer Centre of Health Sciences North - Horizon Sante-Nord
🇨🇦Sudbury, Ontario, Canada
St. Joseph's Healthcare
🇨🇦Toronto, Ontario, Canada
Trillium Health Centre
🇨🇦Toronto, Ontario, Canada
Windsor Regional Cancer Centre
🇨🇦Windsor, Ontario, Canada
Grey Bruce Health Services
🇨🇦Owen Sound, Ontario, Canada
Peterborough Regional Health Centre
🇨🇦Peterborough, Ontario, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Brantford General Hospital
🇨🇦Brantford, Ontario, Canada
London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Juravinski Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Grand River Regional Cancer Centre
🇨🇦Kitchener, Ontario, Canada
The Ottawa Hospital Regional Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Markham Stouffville Hospital
🇨🇦Markham, Ontario, Canada
The Credit Valley Hospital
🇨🇦Mississauga, Ontario, Canada
Stronach Regional Cancer Centre
🇨🇦Newmarket, Ontario, Canada
Mackenzie Health
🇨🇦Richmond Hill, Ontario, Canada
Bluewater Health
🇨🇦Sarnia, Ontario, Canada
The Scarborough Hospital
🇨🇦Scarborough, Ontario, Canada
Niagara Health System
🇨🇦St. Catharines, Ontario, Canada
North York General Hospital
🇨🇦Toronto, Ontario, Canada
Toronto East General Hospital
🇨🇦Toronto, Ontario, Canada
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Sunnybrook Health Sciences - Odette Cancer Centre
🇨🇦Toronto, Ontario, Canada
Humber River Regional Cancer Centre
🇨🇦Toronto, Ontario, Canada