Status:
RECRUITING
Prospective Evaluation of AI R&D Tool for Patient Stratification - MoA Evaluation in Triple Negative Breast Cancer (PEAR-MET)
Lead Sponsor:
Ourotech, Inc.
Collaborating Sponsors:
Guys' and St. Thomas Hospital
Barts & The London NHS Trust
Conditions:
Breast Cancer
Triple Negative Breast Cancer
Eligibility:
All Genders
18+ years
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 test...
Detailed Description
This is a UK-based observational study that aims to discover novel predictive biomarkers with the potential to guide treatment decision making and prolong PFS and OS in patients with advanced TNBC. Pa...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 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.
- Exclusion criteria
- 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.
Exclusion
Key Trial Info
Start Date :
April 30 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06182306
Start Date
April 30 2024
End Date
June 30 2026
Last Update
April 3 2024
Active Locations (3)
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1
Imperial College Healthcare NHS Trust
London, United Kingdom, W6 8RF
2
Barts Hospital NHS Trust
London, United Kingdom
3
Guys and St. Thomas Hospital NHS Trust
London, United Kingdom