Triple Negative Breast Cancer Markers in Liquid Biopsies Using Artificial Intelligence (TRICIA Study)
Trial ID: NCT04874064
Status: RECRUITING
Study type: OBSERVATIONAL
Start date: 2019-12-05
Completion date: 2027-12
Sponsor: Jewish General Hospital
Collaborators: Exactis Innovation
Conditions: Breast Cancer
Interventions: Liquid Biopsy
Locations: St. Joseph's Health Care London; The Ottawa Hospital Cancer Center; Jewish General Hospital
Countries: Canada; Canada; Canada
Enrollment: 130
Age range: 18 Years - None
Sex: ALL

Summary:
Triple negative breast cancer (TNBC) is the most aggressive of breast cancers and it is usually treated with chemotherapy even before surgery. In many cases, the chemotherapy completely "melts" the tumor and these patients do well. When the tumor is not eliminated by the chemotherapy, the patient receive more chemotherapy after surgery to decrease the chances of it coming back. Yet many of these patients don't need that extra chemotherapy and will do well in any case. One of the most exciting recent developments in cancer is the use of "liquid biopsies". It turns out that the tumor's DNA, RNA and proteins can be detected in small vesicles found in the patient's blood. Thanks to advances in Artificial Intelligence, there is now informatics tools to integrate many types of molecular information. Our industrial partner, MIMs, will apply novel informatics tools to generate a test using all the molecular information obtained from blood vesicles and tissue that will be able to find out early if tumor has spread outside of the breast, and how much tumor is left after surgery. The goal is hope to develop a multi-dimensional test for TNBC patients that can be used to decide how much treatment they need and if treatment given after surgery is working.

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.

Outcomes:
Develop signatures of good and poor outcome as well of tumor response to chemotherapy in TNBCs by integrating multidimensional profiling of both tumor and liquid biopsies making use of Artificial Intelligence (AI) tools