TRIple Negative Breast Cancer Markers In Liquid Biopsies Using Artificial Intelligence

NCT04874064 | Recruiting

• 1 other identifier: TRICIA
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Liquid Biopsy; Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

• 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

  3 years

Interventions

Liquid Biopsy OTHER

Blood collection and access to residual tumor.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will be conducted in patients with a diagnosis of breast cancer and pathologically identified as triple negative (not expressing estrogen receptor (ER), progesterone receptor (PR) and HER2 protein, and not showing ERBB2 gene amplification) who will be undergoing neoadjuvant treatment and has residual tumor.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jewish General Hospital: lead
• Exactis Innovation: collaborator

Study Sites (3)

St. Joseph's Health Care London

London, Ontario, N6A 4V2, Canada

RECRUITING

The Ottawa Hospital Cancer Center

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Jewish General Hospital

Montreal, Quebec, H3T 1E1, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tissue and blood sample DNA

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques

Study Officials

• Mark Basik, Dr

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adriana Aguilar, PhD

CONTACT

514-340-8222; nanaaguilar@gmail.com

Josiane Lafleur, MSc

CONTACT

514-340-8222; josiane.lafleur.jgh@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Breast Surgeon

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 5, 2021
• Study Start: December 5, 2019
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)