Image-based AI Predictive Biomarkers for Precision Neoadjuvant Triple-negative Breast Cancer Treatment
Reason given: Lack of funding
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Trial details
- Who runs it
- Ourotech, Inc.
- Trial code
- NCT05435352
- Record updated
- 30 July 2025
- Original description
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).Read full original descriptionShow less
Prospective Evaluation of Image-based Artificial Intelligence Research and Development Tool for Precision Neoadjuvant Triple-Negative Breast Cancer Treatment
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).
Inclusion: Able to give written informed consent prior to admission to this study; Female or male aged ≥18 years; Histologically confirmed invasive primary breast cancer which is triple-negative by the most recent ASCO/College of American Pathologists (CAP) guidelines; Stage I-III breast cancer planned for neoadjuvant chemotherapy followed by surgery; Primary breast tumor size ≥10 mm. For patients with bilateral tumors both of the breast tumors have to be TNBC and at least one has to be ≥10 mm; Willing to undergo a mandatory additional core needle biopsy from the primary breast mass prior to starting neoadjuvant chemotherapy. Patients with bilateral breast cancer only need to have one tumor biopsied if both tumors are ≥10 mm; Willing to donate 40mL of whole blood (cohort B only).
Exclusion: Patients who have already commenced neoadjuvant chemotherapy; Treatment concurrently or within 4 weeks of commencing neoadjuvant chemotherapy with any experimental therapies. Patients who are due to receive standard of care neoadjuvant chemotherapy on the control arm of a trial may be eligible after discussion with the medical monitor; Inflammatory breast cancer; Secretory or adenoid cystic histological subtypes of triple-negative breast cancer; Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent; Inoperable or metastatic TNBC.