Evaluating Whether Integration of Prognostic and Predictive Algorithms Into Routine Clinical Practice Effect Whether Oncologists Order Multigene Assays in Patients With Early Stage Breast Cancer
Evaluating Whether Integration of Prognostic and Predictive Algorithms Into Routine Clinical Practice Effect Whether Oncologists Order Multigene Assays in Patients With Early Stage Breast Cancer
A broad range of prognostic and predictive tools are available for patients with newly
 diagnosed early stage breast cancer. These range from free and publicly available
 mathematical algorithms, through to expensive genomic tests. It is not known how the use of
 these different scores affects physician decision making with respect to ordering genomic
 tests, nor how well these algorithms predict for the results of Oncotype DX ® in the
 real-world setting. This pragmatic study will help to answer these questions.
A broad range of prognostic and predictive tools are available for patients with newly
 diagnosed early stage hormone receptor positive, Her2 negative breast cancer. These range
 from free and publicly available mathematical algorithms (e.g. NHS Predict, Magee formulae,
 Gage and Tennessee equations) that incorporate standard pathology results, through to
 expensive genomic tests (e.g. Oncotype DX ® and Endopredict ®). It is not known how the use
 of these different scores affects physician decision making with respect to ordering genomic
 tests, nor how well these algorithms predict for the results of Oncotype DX ® in the
 real-world setting. This pragmatic study will help to answer these questions.

 In summary: Month 1 to 3: pathology and chemotherapy data is collected, no physician
 questionnaires given. Month 4 to 6: pathology and chemotherapy data collected, plus physician
 questionnaire administered. Intervention teaching after 6 months of study activation. Month 7
 to 9: pathology and chemotherapy data collected, PREDICT 2.1 tool used, no physician
 questionnaire given. Month 10 to 12: pathology and chemotherapy data collected, PREDICT 2.1
 tool used, plus physician questionnaire administered.
Inclusion Criteria:

 -  Histologically confirmed primary breast cancer

 -  No prior chemotherapy

 -  Eligible for Oncotype DX ® testing as per current Ontario funding criteria including:
 ER positive, PR positive or negative, HER2 negative, lymph node status negative or
 micro-invasive disease, tumor >1 cm in size (or if equal or <1 cm, must be grade 2/3
 or have lymph node micrometastasis).

 Exclusion Criteria:

 -  Neoadjuvant treatment including window of opportunity trials

 -  Recurrent breast cancer