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

NCT04131933 | Completed Results

• 1 other identifier: REaCT-Algorithm
• Study Type: observational
• Target: 602
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Breast Cancer

Keywords

Predict 2.1; Oncotype DX

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Time From Resection to Treatment

  12 Months

• Oncotype DX ® Cost

  12 Months

• Physician Survey

  Period 2 (Months 4-6) and Period 4 (Months 10-12)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

• Neoadjuvant treatment including window of opportunity trials
• Recurrent breast cancer

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (6)

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

Grand River Hospital

Kitchener, Ontario, N2G 1G3, Canada

Location

Markham Stouffville Hospital

Markham, Ontario, L3P 7P3, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Location

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, P7B 6V4, Canada

Location

Windsor Regional Hospital

Windsor, Ontario, N8W 1L9, Canada

Location

Related Publications (4)

• 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.

  PMID: 30672056 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.

  PMID: 31287198 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.

  PMID: 31551182 BACKGROUND

• 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.

  PMID: 38534929 RESULT

Related Links

• The Rethinking Clinical Trials (REaCT) website

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Mark Clemons
• Organization: Ottawa Hospital Research Institute

mclemons@toh.ca

+1-613-737-7700

Study Officials

• Arif Awan, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 18, 2019
• Study Start: March 6, 2020
• Primary Completion: May 18, 2022
• Study Completion: May 18, 2022
• Last Updated: December 23, 2025
• Results First Posted: July 29, 2025

Record last verified: 2025-12

Locations

CA (6)