Image-based AI Predictive Biomarkers for Precision Neoadjuvant Triple-negative Breast Cancer Treatment (PEAR-TNBC)

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).

Study Overview

• Status: Terminated
• Conditions: Triple Negative Breast Cancer; Triple Negative Breast Neoplasms
• Intervention / Treatment: Procedure: Core needle biopsy

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.

• Study Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, EC1A 7BE
    • Barts Health NHS Trust
  • London, United Kingdom
    • The Royal Marsden NHS Foundation Trust
  • Manchester, United Kingdom
    • Manchester University NHS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Early TNBC patients due to receive neoadjuvant therapy

Description

Inclusion Criteria:

• 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 Criteria:

• Inflammatory breast cancer.
• Inoperable or metastatic TNBC.
• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Early TNBC patient Cohort A; 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; 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.
Early TNBC patient Cohort B; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 days

Collaborators and Investigators

• Sponsor: Ourotech, Inc.
• Collaborators: Barts & The London NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2022
• Primary Completion (Actual): July 25, 2025
• Study Completion (Actual): July 25, 2025

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 25, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: predictive biomarker; cell culture; computer vision; functional testing; microtumor
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: PEAR-TNBC_ Protocol_v2.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Study Data/Documents

1. Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No