Trial Outcomes & Findings for 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 NCT04131933)

NCT ID: NCT04131933

Last Updated: 2025-12-23

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

602 participants

Primary outcome timeframe

12 Months

Results posted on

2025-12-23

Participant Flow

Participant milestones

Participant milestones
Measure	Period 1 Patients who were seen with clinical and pathological features in Months 0-3	Period 2 Patients who were seen with clinical and pathological features in Months 4-6	Period 3 Patients who were seen with clinical and pathological features in Months 7-9	Period 4 Patients who were seen with clinical and pathological features in Months 10-12
Overall Study STARTED	198	123	125	156
Overall Study COMPLETED	198	123	125	156
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Period 1 n=198 Participants Patients who were seen with clinical and pathological features in Months 0-3	Period 2 n=123 Participants Patients who were seen with clinical and pathological features in Months 4-6	Period 3 n=125 Participants Patients who were seen with clinical and pathological features in Months 7-9	Period 4 n=156 Participants Patients who were seen with clinical and pathological features in Months 10-12	Total n=602 Participants Total of all reporting groups
Age, Continuous	62.3 Years STANDARD_DEVIATION 12.6 • n=198 Participants	64.5 Years STANDARD_DEVIATION 11.7 • n=123 Participants	64.6 Years STANDARD_DEVIATION 11.2 • n=125 Participants	62.3 Years STANDARD_DEVIATION 11.2 • n=156 Participants	63.2 Years STANDARD_DEVIATION 11.8 • n=602 Participants
Sex: Female, Male Female	197 Participants n=198 Participants	122 Participants n=123 Participants	124 Participants n=125 Participants	153 Participants n=156 Participants	596 Participants n=602 Participants
Sex: Female, Male Male	1 Participants n=198 Participants	1 Participants n=123 Participants	1 Participants n=125 Participants	3 Participants n=156 Participants	6 Participants n=602 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 12 Months

Outcome measures

Outcome measures
Measure	Period 1 n=198 Participants Patients who were seen with clinical and pathological features in Months 0-3	Period 2 n=123 Participants Patients who were seen with clinical and pathological features in Months 4-6	Period 3 n=125 Participants Patients who were seen with clinical and pathological features in Months 7-9	Period 4 n=156 Participants Patients who were seen with clinical and pathological features in Months 10-12
Number of Participants With Oncotype DX Testing Ordered	92 Participants	62 Participants	50 Participants	74 Participants

SECONDARY outcome

Timeframe: 12 Months

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Period 1 n=198 Participants Patients who were seen with clinical and pathological features in Months 0-3	Period 2 n=123 Participants Patients who were seen with clinical and pathological features in Months 4-6	Period 3 n=125 Participants Patients who were seen with clinical and pathological features in Months 7-9	Period 4 n=156 Participants Patients who were seen with clinical and pathological features in Months 10-12
Time From Resection to Treatment Resection to radiation	2.4 months Interval 1.0 to 7.9	2.2 months Interval 1.0 to 8.1	2.1 months Interval 1.0 to 6.2	2.3 months Interval 0.9 to 9.1
Time From Resection to Treatment Resection to endocrine therapy	1.8 months Interval 0.0 to 8.2	1.9 months Interval 0.5 to 7.1	2.3 months Interval 0.6 to 7.6	2.2 months Interval 0.5 to 9.8
Time From Resection to Treatment Resection to chemotherapy	1.9 months Interval 1.0 to 3.0	1.8 months Interval 0.2 to 2.5	1.8 months Interval 1.3 to 2.4	1.9 months Interval 0.7 to 3.2

SECONDARY outcome

Timeframe: 12 Months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Period 1 Patients who were seen with clinical and pathological features in Months 0-3	Period 2 n=123 Participants Patients who were seen with clinical and pathological features in Months 4-6	Period 3 Patients who were seen with clinical and pathological features in Months 7-9	Period 4 n=156 Participants Patients who were seen with clinical and pathological features in Months 10-12
Physician Survey PREDICT results make me more confident in my recommendation · Strongly Disagree	0 Participants	1 Participants	0 Participants	3 Participants
Physician Survey PREDICT tool influenced my treatment decision · Strongly Agree	0 Participants	9 Participants	0 Participants	22 Participants
Physician Survey PREDICT results make me more confident in my recommendation · Disagree	0 Participants	8 Participants	0 Participants	12 Participants
Physician Survey PREDICT results make me more confident in my recommendation · Neither Agree nor Disagree	0 Participants	10 Participants	0 Participants	32 Participants
Physician Survey I would use PREDICT tool again · Strongly Disagree	0 Participants	1 Participants	0 Participants	1 Participants
Physician Survey I would use PREDICT tool again · Disagree	0 Participants	1 Participants	0 Participants	5 Participants
Physician Survey PREDICT results make me more confident in my recommendation · Agree	0 Participants	31 Participants	0 Participants	71 Participants
Physician Survey PREDICT results make me more confident in my recommendation · Strongly Agree	0 Participants	12 Participants	0 Participants	31 Participants
Physician Survey I would use PREDICT tool again · Neither Agree nor Disagree	0 Participants	3 Participants	0 Participants	19 Participants
Physician Survey PREDICT tool influenced my treatment decision · Strongly Disagree	0 Participants	3 Participants	0 Participants	7 Participants
Physician Survey PREDICT tool influenced my treatment decision · Disagree	0 Participants	11 Participants	0 Participants	21 Participants
Physician Survey PREDICT tool influenced my treatment decision · Neither Agree nor Disagree	0 Participants	17 Participants	0 Participants	47 Participants
Physician Survey PREDICT tool influenced my treatment decision · Agree	0 Participants	32 Participants	0 Participants	56 Participants
Physician Survey I would use PREDICT tool again · Agree	0 Participants	41 Participants	0 Participants	68 Participants
Physician Survey I would use PREDICT tool again · Strongly Agree	0 Participants	27 Participants	0 Participants	60 Participants

Adverse Events

Period 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Period 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Period 3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Period 4

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mark Clemons

Ottawa Hospital Research Institute

Phone: +1-613-737-7700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place