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

Launched by OUROTECH, INC. · Dec 22, 2023

Keywords

ClinConnect Summary

The PEAR-MET clinical trial is studying a new device developed by Pear Bio that helps doctors understand how well a patient’s tumor might respond to different treatments for triple-negative breast cancer. This trial is specifically for patients who have advanced or metastatic triple-negative breast cancer and are about to start a new line of therapy. The goal is to see how accurately the Pear Bio test can predict a patient's response to the treatment, which could help tailor therapy to each individual.

To participate in this trial, you need to be at least 18 years old, have been diagnosed with triple-negative breast cancer, and be planning to start or change your treatment. You'll be asked to provide a small tissue sample and a blood sample before beginning your new therapy. While the trial is ongoing, your doctor won’t know the results from the Pear Bio test, which helps ensure the study's fairness. If you decide to join, you may play a crucial role in helping researchers learn more about how to improve treatment for future patients with this type of cancer.

Gender

ALL

Eligibility 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.