Status:
TERMINATED
Image-based AI Predictive Biomarkers for Precision Neoadjuvant Triple-negative Breast Cancer Treatment
Lead Sponsor:
Ourotech, Inc.
Collaborating Sponsors:
Barts & The London NHS Trust
Conditions:
Triple Negative Breast Cancer
Triple Negative Breast Neoplasms
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 chemotherapy regimens can be tested s...
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 receivi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 6 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 25 2025
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT05435352
Start Date
June 6 2022
End Date
July 25 2025
Last Update
July 30 2025
Active Locations (3)
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1
Barts Health NHS Trust
London, United Kingdom, EC1A 7BE
2
The Royal Marsden NHS Foundation Trust
London, United Kingdom
3
Manchester University NHS
Manchester, United Kingdom