Breast CancerREaCT-AlgorithNCT04131933
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
An observational study of Breast Cancer, run by Ottawa Hospital Research Institute at 6 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 602 participants
- Where
- 6 sitesCanada
- Study dates
- 6 Mar 2020to 18 May 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- Neoadjuvant treatment including window of opportunity trials
- Recurrent breast cancer
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
Grand River Hospital
Kitchener, Ontario, N2G 1G3
Markham Stouffville Hospital
Markham, Ontario, L3P 7P3
Ottawa Hospital Research Institute
Ottawa, Ontario
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4
Windsor Regional Hospital
Windsor, Ontario, N8W 1L9
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer
- Keywords
- Predict 2.1, Oncotype DX
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Months
Secondary outcomes (3)
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.
Measured: 12 Months
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.
Measured: 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.
Measured: Period 2 (Months 4-6) and Period 4 (Months 10-12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start6 Mar 2020
- Primary completion18 May 2022
- Study completion18 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arif Awan, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131933
- Sponsor's protocol ID
- REaCT-Algorithm
- Acronym
- REaCT-Algorith
- Status last verified
- Dec 2025
- First submitted
- 1 Oct 2019
- Last updated
- 23 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30672056de 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.
PubMed 31287198Robertson 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.
PubMed 31551182Awan 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.
PubMed 38534929
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04131933
- Acronym / sponsor ID
- REaCT-Algorith / REaCT-Algorithm
- Conditions
- Breast Cancer
- Keywords
- Predict 2.1, Oncotype DX
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 602 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 18 May 2022 (actual)
- Study completion
- 18 May 2022 (actual)
- First posted
- 18 Oct 2019 (actual)
- Results
- Posted 29 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- Neoadjuvant treatment including window of opportunity trials
- Recurrent breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With Oncotype DX Testing Ordered
Time frame: 12 Months
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.
3 secondary outcomes
Time From Resection to Treatment
Time frame: 12 Months
Oncotype DX ® Cost
Time frame: 12 Months
Physician Survey
Time frame: Period 2 (Months 4-6) and Period 4 (Months 10-12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30672056Robertson 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.
- Background: PubMed 31287198de 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.
- Background: PubMed 31551182Robertson 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.
- Results publication: PubMed 38534929Awan 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.
- The Rethinking Clinical Trials (REaCT) websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arif Awan, MD principal investigator
Ottawa Hospital Research Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Ottawa Hospital Research Institute at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Oncotype DX Testing Ordered (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04131933, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.