Prospective Evaluation of AI R&D Tool for Patient Stratification - MoA Evaluation in Triple Negative Breast Cancer (PEAR-MET)

NCT06182306 | Recruiting

• 1 other identifier: PEAR-MET
• Study Type: observational
• Target: 30
• 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 systemic therapy regimens can be tested simultaneously ex vivo. This study will recruit patients with advanced or metastatic triple negative breast cancer who are due to start a clinically-indicated new line of therapy. The oncologist will be blinded to the response on the Pear Bio tool (the assay will be run in parallel with the patient's treatment). The primary objective of this study is to establish the sensitivity and specificity of Pear Bio's test against patient outcomes (response, progression-free survival, overall survival)

Conditions

Breast Cancer; Triple Negative Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Establish a functional dose of each commonly used FDA approved therapeutic/combination

  To conduct dose-response analysis for each commonly used FDA approved therapy, or combination of therapies, to establish the correct dose in the Pear Bio system

  6 months

Secondary Outcomes (3)

• ORR prediction accuracy

  3 months

• PFS prediction accuracy

  12-24 months

• OS prediction accuracy

  2 years

Other Outcomes (2)

• Culture success rate

  4 days

• Assess the correlation of various "omic" biomarkers to patient PFS, ORR and/or OS

  2 years

Study Arms (1)

Trial Cohort

Patients with advanced or metastatic triple negative breast cancer, due to start a new line of systemic therapy (targeted drug or immunotherapy)

Procedure: Biopsy

Interventions

Biopsy PROCEDURE

Patients undergo a biopsy from a lesion, and give 40ml of blood

Trial Cohort

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

Patients with advanced or metastatic triple negative breast cancer, due to start a new line of 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 primary breast cancer which is triple-negative by the most recent ASCO/College of American Pathologists (CAP) guidelines.
• Stage 4 or locally advanced breast cancer planned for first line systemic therapy, or has received prior lines of systemic therapy and is due to undergo another line of systemic therapy.
• Willing and able to undergo a mandatory additional core needle biopsy (minimum 2 cores) or equivalent fine needle aspiration from the primary breast mass or a metastasis prior to starting the subsequent line of systemic therapy.
• Willing and able to undergo a mandatory procedure to collect 40 mL of blood.

You may not qualify if:

• Tumours not confirmed as triple negative breast cancer.
• Early stage TNBC.
• Patients with TNBC that do not intend to receive systemic therapy.
• Patients who have already commenced systemic therapy with no plans of changing the systemic therapy after the collection of the core needle biopsy or fine needle aspirate sample.
• Patients who are due to receive experimental therapies that are not included in the study protocol.
• Haemoglobin levels below 80g/L prior to research sample collection.
• 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
• Guys' and St. Thomas Hospital: collaborator
• Barts & The London NHS Trust: collaborator
• Imperial College Healthcare NHS Trust: collaborator
• Nottingham University Hospitals Trust: collaborator
• Hampshire Hospitals NHS Foundation Trust: collaborator

Study Sites (3)

Imperial College Healthcare NHS Trust

London, W6 8RF, United Kingdom

NOT YET RECRUITING

Barts Hospital NHS Trust

London, United Kingdom

RECRUITING

Guys and St. Thomas Hospital NHS Trust

London, United Kingdom

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumor cores and blood

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Sheeba Irshad, MD PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Duleek Ranatunga

CONTACT

+44 7716558079; duleek@pearbio.com

Elli Tham

CONTACT

elli.tham@pearbio.com

Study Design

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

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 26, 2023
• Study Start: April 30, 2024
• Primary Completion: September 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)