Using AI to predict treatment response in triple-negative breast cancer
Prospective Evaluation of Image-based Artificial Intelligence Research and Development Tool for Precision Neoadjuvant Triple-Negative Breast Cancer Treatment
This study is testing a new tool that uses AI to see if it can predict how well early-stage triple-negative breast cancer patients will respond to chemotherapy before they start treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ourotech, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (London and 2 other locations) |
| Trial ID | NCT05435352 on ClinicalTrials.gov |
What this trial studies
This observational pilot study aims to evaluate the accuracy of the Pear Bio tool, an organ-on-a-chip device, in predicting the response of early-stage triple-negative breast cancer (TNBC) patients to neoadjuvant chemotherapy. Patients will undergo a mandatory biopsy before starting chemotherapy, and the results from the Pear Bio tool will be compared to the pathological outcomes after surgery. The treating oncologist will remain blinded to the assay results to ensure unbiased treatment decisions. The primary goal is to establish the sensitivity and specificity of the Pear Bio tool against patient outcomes, specifically focusing on pathological complete response.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed early-stage triple-negative breast cancer planned for neoadjuvant chemotherapy.
Not a fit: Patients with inflammatory breast cancer, inoperable or metastatic TNBC, or those who have already started neoadjuvant chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized treatment plans for patients with triple-negative breast cancer, potentially improving outcomes.
How similar studies have performed: While the use of AI in predicting treatment responses is an emerging field, this specific approach using the Pear Bio tool is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
London and 2 other locations
- Barts Health NHS Trust — London, United Kingdom (Recruiting)
- The Royal Marsden NHS Foundation Trust — London, United Kingdom (Recruiting)
- Manchester University NHS — Manchester, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Duleek Ranatunga
- Email: duleek@pearbio.com
- Phone: +44 7716558079
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.