Using AI to find triple-negative breast cancer markers in blood and tissue

Triple Negative Breast Cancer Markers in Liquid Biopsies Using Artificial Intelligence (TRICIA Study)

We will test whether AI analysis of blood 'liquid biopsies' and tissue can find markers that predict outcomes for people with triple-negative breast cancer who still have tumor after chemotherapy.

Quick facts

• Study type: Observational
• Enrollment: 130 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jewish General Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 3 sites (London, Ontario and 2 other locations)
• Trial ID: NCT04874064 on ClinicalTrials.gov

What this trial studies

Researchers will collect serial blood samples (liquid biopsies) and tissue from people with triple-negative breast cancer who have clinical, radiologic, or pathologic evidence of residual tumor after neoadjuvant chemotherapy. Molecular information including tumor DNA, RNA, and proteins from blood vesicles and tissue will be integrated using novel artificial intelligence informatics provided by an industry partner to develop multi-dimensional biomarkers. The project enrolls two cohorts: patients sampled before surgery with evidence of residual disease and patients sampled after surgery with pathologically confirmed residual tumor, with scheduled follow-up blood draws within six weeks and over the next six months. This is an observational biomarker-development effort that does not change standard treatment but seeks links between molecular signatures and clinical outcomes.

Who should consider this trial

Good fit: Adults with triple-negative breast cancer who have completed at least eight weeks of neoadjuvant chemotherapy and have clinical, radiologic, or pathological evidence of residual tumor and can attend serial clinic visits and blood draws are ideal candidates.

Not a fit: Patients who achieve a complete pathological response (no residual tumor), cannot provide serial blood samples, or cannot attend follow-up visits are unlikely to benefit from this biomarker effort.

Why it matters

Potential benefit: If successful, the test could identify patients who do not need extra post-surgical chemotherapy and spare them unnecessary treatment.

How similar studies have performed: Aside from BRCA1/2 where clinical utility is established, few biomarkers have proven useful in TNBC and liquid-biopsy plus AI approaches are promising but remain largely novel and unproven in this setting.

Eligibility criteria

Inclusion Criteria:

* Triple negative (ER negative, PR negative and Her2 negative as defined by local standards). ER \<10% is acceptable.
* Patients who have completed a minimum of 8 weeks of neoadjuvant chemotherapy.
* A cohort of TNBC patients who are awaiting surgery that have clinical or radiological evidence of residual tumor prior to surgery. This evaluation will be made at the discretion of the treating physician.

OR A second cohort of TNBC patients will be recruited after surgery, in which pathological evaluation has demonstrated the presence of residual tumor post-surgery.

* Patients who can come to the clinic for standard of care follow-up within 6 weeks post-surgery and in the next 6 months after surgery.
* Patients who are willing to provide serial blood samples.
* Participants must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study.

Exclusion Criteria:

* Clinical or radiological evidence of metastatic disease.
* Patient with a recurrence of breast cancer.
* Patients who have not had neoadjuvant chemotherapy or less than 8 weeks of neoadjuvant chemotherapy.
* Patient who received radiotherapy treatment prior to surgery.
* Patients who are not capable of signing or understanding the informed consent form.
* Known infection with HIV or hepatitis.

Where this trial is running

London, Ontario and 2 other locations

• St. Joseph's Health Care London — London, Ontario, Canada (Recruiting)
• The Ottawa Hospital Cancer Center — Ottawa, Ontario, Canada (Recruiting)
• Jewish General Hospital — Montreal, Quebec, Canada (Recruiting)

Study contacts

• Principal investigator: Mark Basik, Dr — Study Principal Investigator
• Study coordinator: Adriana Aguilar, PhD

Conditions Breast Cancer; Liquid Biopsy; Artificial Intelligence