An observational study in Triple Negative Breast Cancer and Triple Negative Breast Neoplasms, sponsored by Ourotech, Inc.. Terminated at 3 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-30.
Sponsored by Ourotech, Inc. · Observational
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).
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.
1,140 studies on the registry are indexed under Triple Negative Breast Neoplasms; 442 are open to participants now.
This study's enrollment of 34 is below the median of 186 across 103 observational studies indexed under Triple Negative Breast Neoplasms.
Browse Triple Negative Breast Neoplasms studies →Ourotech, Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Early TNBC patients due to receive neoadjuvant therapy
Exclusion Criteria:
Early TNBC patients receiving neoadjuvant therapy and providing core needle biopsy. Any approved neoadjuvant therapy can be used based on physician's choice.
Procedure: Core needle biopsy
Early TNBC patients receiving neoadjuvant therapy and providing core needle biopsy and blood. Any approved neoadjuvant therapy can be used based on physician's choice.
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.
Pathological complete response correlation accuracy (specificity)
The specificity of Pear image-based biomarkers are established against patient pathological complete response (evaluated on surgical sample post-neoadjuvant therapy).
Time frame: 6 months
Pathological complete response correlation accuracy (sensitivity)
The sensitivity of Pear image-based biomarkers are established against patient pathological complete response (evaluated on surgical sample post-neoadjuvant therapy).
Time frame: 6 months
Pathological complete response correlation accuracy (positive predictive value)
The positive predictive value of Pear image-based biomarkers are established against patient pathological complete response (evaluated on surgical sample post-neoadjuvant therapy).
Time frame: 6 months
Pathological complete response correlation accuracy (negative predictive value)
The negative predictive value of Pear image-based biomarkers are established against patient pathological complete response (evaluated on surgical sample post-neoadjuvant therapy).
Time frame: 6 months
Culture success rate
The percentage of patient samples successfully arriving at central lab with \>100k live cells isolated and maintaining 70% cell viability after 4 days in culture with no treatment
Time frame: 4 days
Plan to share: No — Pseudonymized data will be shared between study sites, such as treatment and outcome data for each patient. No publication will be made revealing individual patient data; only group-level data will be published.
No publications or documents are linked to this record.
This study is terminated, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Ourotech, Inc.