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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: nanaaguilar@gmail.com
• Phone: 514-340-8222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.