Evaluating an AI tool for patient treatment in advanced triple negative breast cancer
Prospective Evaluation of AI R&D Tool for Patient Stratification - Mechanism of Action Evaluation in Triple Negative Breast Cancer (PEAR-MET)
This study is testing a new AI tool that looks at tumor samples from patients with advanced triple negative breast cancer to see if it can help predict how well different treatments will work for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ourotech, Inc. Industry-sponsored |
| Locations | 3 sites (London and 2 other locations) |
| Trial ID | NCT06182306 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate an organ-on-a-chip device developed by Pear Bio, which utilizes a computer vision pipeline to assess how individual tumors respond to various systemic therapies. Patients with advanced or metastatic triple negative breast cancer will undergo a biopsy before starting a new line of therapy, with their tumor samples tested ex vivo while their oncologist remains blinded to the results. The primary goal is to determine the sensitivity and specificity of the Pear Bio test in predicting patient outcomes such as response rates and survival. The study will also explore novel predictive biomarkers to aid in treatment decision-making.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed advanced or metastatic triple negative breast cancer who are about to start a new line of systemic therapy.
Not a fit: Patients with early-stage triple negative breast cancer or those not intending to receive systemic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment options for patients with advanced triple negative breast cancer, potentially improving their survival outcomes.
How similar studies have performed: While this approach is innovative, similar studies evaluating predictive biomarkers in cancer treatment have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria 1. Able to give written informed consent prior to admission to this study. 2. Female or male aged ≥18 years. 3. 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. 4. 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. 5. Willing and able to undergo a mandatory procedure to collect 40 mL of blood. Exclusion criteria 1. Tumours not confirmed as triple negative breast cancer. 2. Early stage TNBC. 3. Patients with TNBC that do not intend to receive systemic therapy. 4. 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. 5. Patients who are due to receive experimental therapies that are not included in the study protocol. 6. Haemoglobin levels below 80g/L prior to research sample collection. 7. 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
- Imperial College Healthcare NHS Trust — London, 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)
Study contacts
- Principal investigator: Sheeba Irshad, MD PhD — King's College London
- 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.