Trial details

Trial short name: TRICIA study

Official title: Triple negative breast Cancer markers in liquid biopsies using artificial intelligence

Principal Investigator:

Cancer type:
Cancer location:
Disease stage: Early Cancer
Trial phase: Other
Intervention: Observational study: Chemotherapy - capecitabine

Registration #: TRICIA study

Trial description:
The purpose of this study is to look at cancer characteristics for good and poor outcomes to chemotherapy in patients with breast cancer. Patients with triple negative breast cancer (TNBC) who have received chemotherapy, have evidence of remaining tumor, and who meet a certain criteria may be able to participate. Patients will have their tumour and blood samples analysed using artificial intelligence tools (AI). The AI tools will be used to predict outcomes while incorporating various pieces of genetic information. Patients will receive as part of their standard of care either capecitabine chemotherapy or another chemotherapy medication after surgery. The goal is to identify which patients will benefit from the capecitabine treatment. Patients will know the treatment they are receiving.

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. • 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.