Clinical trial · Observational
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 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of Participants With Oncotype DX Testing Ordered
- timeFrame
- 12 Months
- description
- To assess whether providing individual patient prognostic and predictive scores from PREDICT 2.1 affects the rate of subsequent requests for Oncotype DX ® testing. This is measured as the number of participants with Oncotype DX ® testing ordered.
Secondary outcomes (3)
- measure
- Time From Resection to Treatment
- timeFrame
- 12 Months
- description
- To assess whether routine availability of PREDICT 2.1 affects adjuvant treatment (chemotherapy, radiation therapy and endocrine therapy). This will be done by identifying the time to starting chemotherapy, endocrine therapy or radiation therapy.
- measure
- Oncotype DX ® Cost
- timeFrame
- 12 Months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDRobertson SJ, Ibrahim MFK, Stober C, Hilton J, Kos Z, Mazzarello S, Ramsay T, Fergusson D, Vandermeer L, Mallick R, Arnaout A, Dent SF, Segal R, Sehdev S, Gertler S, Hutton B, Clemons M. Does integration of Magee equations into routine clinical practice affect whether oncologists order the Oncotype DX test? A prospective randomized trial. J Eval Clin Pract. 2019 Apr;25(2):196-204. doi: 10.1111/jep.13094. Epub 2019 Jan 23. PMID 30672056
- BACKGROUNDde Lima MAG, Clemons M, Van Katwyk S, Stober C, Robertson SJ, Vandermeer L, Fergusson D, Thavorn K. Cost analysis of using Magee scores as a surrogate of Oncotype DX for adjuvant treatment decisions in women with early breast cancer. J Eval Clin Pract. 2020 Jun;26(3):889-892. doi: 10.1111/jep.13223. Epub 2019 Jul 9. PMID 31287198
- BACKGROUNDRobertson SJ, Pond GR, Hilton J, Petkiewicz SL, Ayroud Y, Kos Z, Gravel DH, Stober C, Vandermeer L, Arnaout A, Clemons M. Selecting Patients for Oncotype DX Testing Using Standard Clinicopathologic Information. Clin Breast Cancer. 2020 Feb;20(1):61-67. doi: 10.1016/j.clbc.2019.07.006. Epub 2019 Aug 22. PMID 31551182
- RESULTAwan AA, Saunders D, Pond G, Hamm C, Califaretti N, Mates M, Kumar V, Ibrahim MFK, Beltran-Bless AA, Vandermeer L, Hilton J, Clemons M. Does Pre-Emptive Availability of PREDICT 2.1 Results Change Ordering Practices for Oncotype DX? A Multi-Center Prospective Cohort Study. Curr Oncol. 2024 Feb 27;31(3):1278-1290. doi: 10.3390/curroncol31030096. PMID 38534929