Image-based AI Predictive Biomarkers for Precision Neoadjuvant Triple-negative Breast Cancer Treatment

Launched by OUROTECH, INC. · Jun 22, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new tool developed by Pear Bio that uses an organ-on-a-chip device to test how well a patient's tumor responds to different chemotherapy treatments. The goal is to see if this tool can accurately predict how effective these treatments will be for individuals with early-stage triple-negative breast cancer (TNBC) before they start their standard chemotherapy and surgery. In this study, the oncologist will not know the results from the tool while the patient is receiving treatment, which helps ensure unbiased results.

To participate, patients must be at least 18 years old, have confirmed triple-negative breast cancer, and be planning to start standard chemotherapy before surgery. They need to have a tumor size of at least 10 mm and be willing to undergo a biopsy of the tumor before starting treatment. Participants will also need to provide a small blood sample if they are in a specific group of the study. It's important to note that individuals with certain types of breast cancer or those who have already begun chemotherapy cannot join the trial. Overall, this study aims to help doctors personalize treatment plans for patients based on how their specific tumors respond to different chemotherapy options.

Gender

ALL

Eligibility 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.