NCT05435352

Image-based AI Predictive Biomarkers for Precision Neoadjuvant Triple-negative Breast Cancer Treatment

Prospective Evaluation of Image-based Artificial Intelligence Research and Development Tool for Precision Neoadjuvant Triple-Negative Breast Cancer Treatment

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 34 (actual)
• Sponsor: Ourotech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Pear Bio has developed an organ-on-a-chip device together with a computer vision pipeline through which the response of an individual patient's tumor to different chemotherapy regimens can be tested simultaneously ex vivo. This study will recruit patients with early TNBC who are planned for standard of care neoadjuvant chemotherapy followed by surgery. The oncologist will be blinded to the response on the Pear Bio tool (the assay will be run in parallel with the patient's neoadjuvant chemotherapy). The primary objective of this study is to establish the sensitivity and specificity of Pear Bio's test against patient outcomes (pathological complete response).

Detailed description

This is a multicenter, UK-based, observational pilot study that aims to determine the accuracy of a new assay, the Pear Bio tool, in predicting pathological complete response (pCR) in patients receiving neoadjuvant chemotherapy for early TNBC. Patients will undergo an additional, mandatory biopsy of the breast tumor before commencing neoadjuvant chemotherapy. The biopsy sample will be run on the Pear Bio tool while the patient receives their standard of care neoadjuvant chemotherapy. As such, for this study, the result from the Pear Bio tool will not be used to inform the choice of neoadjuvant chemotherapy and the treating oncologist will be blinded to the assay results. The pathological outcome from surgery (pCR vs non-pCR) will be collected and used to calculate the specificity of the assay as the primary endpoint of the study. Sensitivity, positive predictive value and negative predictive value will also be measured.

Conditions

• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Interventions

Type	Name	Description
PROCEDURE	Core needle biopsy	An additional core needle biopsy is taken to run the Pear Bio test. Test results are not used to inform treatment. Approved neoadjuvant therapy regimens are given to the patient as per standard of care to observe response.

Timeline

• Start date: 2022-06-06
• Primary completion: 2025-07-25
• Completion: 2025-07-25
• First posted: 2022-06-28
• Last updated: 2025-07-30

Locations

3 sites across 1 country: United Kingdom