N/A
Completed N=602
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
Source: ClinicalTrials.gov NCT04131933 ↗Enrolled (actual)
602
Serious AEs
—
Results posted
Jul 2025
Primary outcomePrimary: Number of Participants With Oncotype DX Testing Ordered — 92; 62; 50; 74 Participants — p=0.37
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Oncotype DX Testing Ordered |
92; 62; 50; 74 | 0.37 |
| SECONDARY Time From Resection to Treatment |
1.9; 1.8; 1.8; 1.9; 2.4; 2.2 | — |
| SECONDARY Oncotype DX ® Cost |
— | — |
| SECONDARY Physician Survey |
0; 1; 0; 3; 0; 8 | — |
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
Data sourced from ClinicalTrials.gov (NCT04131933). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.