Trial results for a study investigating how prognostic and predictive algorithms influence multigene assay ordering in early-stage breast cancer were posted on ClinicalTrials.gov on 2025-07-29, with 602 participants enrolled.
Background
For patients diagnosed with early-stage breast cancer, a variety of prognostic and predictive tools are available to guide treatment decisions. These tools range from publicly accessible mathematical algorithms to advanced genomic tests like Oncotype DX. Understanding how the integration and use of these different scores affect physician decision-making, particularly concerning the ordering of genomic tests, is crucial for optimizing patient care. This pragmatic study aimed to investigate these dynamics and assess how well these algorithms predict Oncotype DX results in a real-world clinical setting.
Trial design
This completed study enrolled 602 participants with Breast Cancer. The trial's objective was to evaluate whether the integration of prognostic and predictive algorithms into routine clinical practice affects oncologists' decisions to order multigene assays in patients with early-stage breast cancer. The study design involved observing ordering patterns over different periods.
Key results
The trial reported key measurements related to Oncotype DX testing orders and time to treatment:
- Number of Participants With Oncotype DX Testing Ordered:
- In Period 1, 92 participants had Oncotype DX testing ordered.
- In Period 2, 62 participants had Oncotype DX testing ordered.
- In Period 3, 50 participants had Oncotype DX testing ordered.
- In Period 4, 74 participants had Oncotype DX testing ordered.
- Time From Resection to Treatment (first set of measurements):
- The median time was 1.9 months (Full Range) in Period 1.
- The median time was 1.8 months (Full Range) in Period 2.
- The median time was 1.8 months (Full Range) in Period 3.
- The median time was 1.9 months (Full Range) in Period 4.
- Time From Resection to Treatment (second set of measurements):
- The median time was 2.4 months (Full Range) in Period 1.
- The median time was 2.2 months (Full Range) in Period 2.
- The median time was 2.1 months (Full Range) in Period 3.
- The median time was 2.3 months (Full Range) in Period 4.
A Fisher Exact analysis comparing pre-intervention (Period 1 and Period 2) versus post-intervention (Period 3 and Period 4) periods yielded a p-value of 0.37.
What this means
The results indicate variations in the number of Oncotype DX tests ordered across different periods of the study. While the raw numbers show fluctuations, the statistical analysis using a Fisher Exact test, comparing pre-intervention and post-intervention periods, resulted in a p-value of 0.37. This suggests that there was no statistically significant difference in the rate of Oncotype DX testing orders between the pre- and post-intervention phases of the study. The median time from resection to treatment remained relatively consistent across all periods, ranging from 1.8 to 2.4 months, depending on the measurement set. These findings contribute to understanding the real-world impact of integrating prognostic and predictive algorithms on clinical decision-making regarding multigene assays in early-stage breast cancer.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04131933, titled "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", were posted on 2025-07-29 on clinicaltrials.gov.