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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

NCT ID: NCT04131933

Last Updated: 2025-12-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

602 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-06

Study Completion Date

2022-05-18

Brief Summary

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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.

Detailed Description

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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

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Breast Cancer

Keywords

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Predict 2.1 Oncotype DX

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ottawa Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arif Awan, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

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Kingston Health Sciences Centre

Kingston, Ontario, Canada

Site Status

Grand River Hospital

Kitchener, Ontario, Canada

Site Status

Markham Stouffville Hospital

Markham, Ontario, Canada

Site Status

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Site Status

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, Canada

Site Status

Windsor Regional Hospital

Windsor, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 30672056 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31287198 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31551182 (View on PubMed)

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.

Reference Type RESULT
PMID: 38534929 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://react.ohri.ca/

The Rethinking Clinical Trials (REaCT) website

Other Identifiers

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REaCT-Algorithm

Identifier Type: -

Identifier Source: org_study_id