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

NCT05435352 | Terminated DMC

• 1 other identifier: PEAR-TNBC_ Protocol_v2.0
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Triple Negative Breast Cancer; Triple Negative Breast Neoplasms

Keywords

computer vision; cell culture; microtumor; functional testing; predictive biomarker

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pathological complete response correlation accuracy (sensitivity)

  6 months

• Pathological complete response correlation accuracy (positive predictive value)

  6 months

• Pathological complete response correlation accuracy (negative predictive value)

  6 months

Other Outcomes (1)

• Culture success rate

  4 days

Study Arms (2)

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

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

Interventions

Core needle biopsy PROCEDURE

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 A; Early TNBC patient Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Early TNBC patients due to receive neoadjuvant therapy

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ourotech, Inc.: lead
• Barts & The London NHS Trust: collaborator

Study Sites (3)

Barts Health NHS Trust

London, EC1A 7BE, United Kingdom

Location

The Royal Marsden NHS Foundation Trust

London, United Kingdom

Location

Manchester University NHS

Manchester, United Kingdom

Location

Biospecimen

Retention: NONE RETAINED

Tumor cores

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Biopsy, Large-Core Needle

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: June 28, 2022
• Study Start: June 6, 2022
• Primary Completion: July 25, 2025
• Study Completion: July 25, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)