A Prospective Cohort Study to Evaluate the Oncotype DX® Test in Early Stage Breast Cancer
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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Change in treatment recommendation
The primary outcome is the change in treatment recommendation by the oncologist and the change in treatment preference of the patient.
One month
No
Mark N. Levine, MD
Principal Investigator
Ontario Clinical Oncology Group (OCOG)
Canada: Ministry of Health & Long Term Care, Ontario
OCOG-2011-ONCOTYPEDX
NCT01423890
January 2012
March 2014
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