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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Oncotype DX Testing Ordered | 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. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Resection to Treatment | 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. | 12 Months |
| Oncotype DX ® Cost |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Arif Awan, MD | Ottawa Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kingston Health Sciences Centre | Kingston | Ontario | K7L 2V7 | Canada | ||
| Grand River Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30672056 | Background | Robertson 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. | |
| 31287198 |
| Label | URL |
|---|---|
| The Rethinking Clinical Trials (REaCT) website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Period 1 | Patients who were seen with clinical and pathological features in Months 0-3 |
| FG001 | Period 2 | Patients who were seen with clinical and pathological features in Months 4-6 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 14, 2020 |
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Prognostic risk scores, including Magee formulae, Gage and Tennessee equations will be calculated using patient and tumour characteristics. These scores will be compared with Oncotype DX ® scores when performed. These will be used to determine Oncotype DX ® cost and total health system costs and subsequent health care utilization. |
| 12 Months |
| Physician Survey | A physician survey will be used to assess physician comfort when making systemic therapy decisions.It will determine whether the routine availability of PREDICT 2.1 score in the clinic enhanced their comfort with systemic therapy decision-making. | Period 2 (Months 4-6) and Period 4 (Months 10-12) |
| Kitchener |
| Ontario |
| N2G 1G3 |
| Canada |
| Markham Stouffville Hospital | Markham | Ontario | L3P 7P3 | Canada |
| Ottawa Hospital Research Institute | Ottawa | Ontario | Canada |
| Thunder Bay Regional Health Sciences Centre | Thunder Bay | Ontario | P7B 6V4 | Canada |
| Windsor Regional Hospital | Windsor | Ontario | N8W 1L9 | Canada |
| Background |
| de 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. |
| 31551182 | Background | Robertson 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. |
| 38534929 | Result | Awan 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. |
| FG002 | Period 3 | Patients who were seen with clinical and pathological features in Months 7-9 |
| FG003 | Period 4 | Patients who were seen with clinical and pathological features in Months 10-12 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Period 1 | Patients who were seen with clinical and pathological features in Months 0-3 |
| BG001 | Period 2 | Patients who were seen with clinical and pathological features in Months 4-6 |
| BG002 | Period 3 | Patients who were seen with clinical and pathological features in Months 7-9 |
| BG003 | Period 4 | Patients who were seen with clinical and pathological features in Months 10-12 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Oncotype DX Testing Ordered | 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. | Posted | Count of Participants | Participants | 12 Months |
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| Secondary | Time From Resection to Treatment | 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. | The overall number of participants analyzed are the number of participants in each period. Each row in the outcome measure data table has a different number of participants analyzed per period because not every participant received each treatment type (chemotherapy, radiation, endocrine therapy). | Posted | Median | Full Range | months | 12 Months |
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| Secondary | Oncotype DX ® Cost | Prognostic risk scores, including Magee formulae, Gage and Tennessee equations will be calculated using patient and tumour characteristics. These scores will be compared with Oncotype DX ® scores when performed. These will be used to determine Oncotype DX ® cost and total health system costs and subsequent health care utilization. | Not Posted | Dec 2027 | 12 Months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Physician Survey | A physician survey will be used to assess physician comfort when making systemic therapy decisions.It will determine whether the routine availability of PREDICT 2.1 score in the clinic enhanced their comfort with systemic therapy decision-making. | Survey was only administered in Period 2 and Period 4. The number analyzed for each row differs from the overall number of participants analyzed because some surveys may have been incomplete and some items left unanswered. | Posted | Count of Participants | Participants | Period 2 (Months 4-6) and Period 4 (Months 10-12) |
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Adverse events were not collected.
Adverse events were not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Period 1 | Patients who were seen with clinical and pathological features in Months 0-3 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Period 2 | Patients who were seen with clinical and pathological features in Months 4-6 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Period 3 | Patients who were seen with clinical and pathological features in Months 7-9 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Period 4 | Patients who were seen with clinical and pathological features in Months 10-12 | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Clemons | Ottawa Hospital Research Institute | +1-613-737-7700 | 70170 | mclemons@toh.ca |
| Mar 27, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Patients who were seen with clinical and pathological features in Months 10-12
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| Title | Measurements |
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| Disagree |
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| Neither Agree nor Disagree |
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| Agree |
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| Strongly Agree |
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