Clinical trial NCT04131933: 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
Official title: A Multi-centre, Prospective, Observational Study 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Predict 2.1
Oncotype DX
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 602
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that are eligible for Oncotype DX ® testing under current funding parameters with complete pathology reports for newly diagnosed early stage breast cancer will be eligible for this prospective trial.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of requests for Oncotype DX testing
timeFrame: 12 Months
Secondary outcomes:
measure: Routine availability of PREDICT 2.1
timeFrame: 12 Months
measure: Oncotype DX ® cost
timeFrame: 12 Months
measure: Physician survey
timeFrame: 3 months and 9 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Arif Awan, MD
role: PRINCIPAL_INVESTIGATOR
References: