Status:
RECRUITING
TRIple Negative Breast Cancer Markers In Liquid Biopsies Using Artificial Intelligence
Lead Sponsor:
Jewish General Hospital
Collaborating Sponsors:
Exactis Innovation
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Brief 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 tu...
Detailed Description
Rationale: The most aggressive form of breast cancer is triple negative breast cancer (TNBC), so called because these tumors do not express hormone receptors or HER2 receptor, and therefore have no re...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 5 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04874064
Start Date
December 5 2019
End Date
December 1 2027
Last Update
November 28 2025
Active Locations (3)
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1
St. Joseph's Health Care London
London, Ontario, Canada, N6A 4V2
2
The Ottawa Hospital Cancer Center
Ottawa, Ontario, Canada, K1H 8L6
3
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E1