TRIple Negative Breast Cancer Markers In Liquid Biopsies Using Artificial Intelligence (TRICIA)

November 21, 2025 updated by: Mark Basik, Jewish General Hospital

Triple Negative Breast Cancer Markers in Liquid Biopsies Using Artificial Intelligence (TRICIA Study)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 readily targetable molecules. Chemotherapy is the only treatment, with chemoresistance signaling a very poor outcome even in early TNBC. The presence of residual tumor at surgery (non-pathological complete response or non-pCR) signals chemoresistance and poor prognosis, with about 30-40% of these patients dying of TNBC within the first 5 years after surgery. A recent clinical trial showed that the addition of further chemotherapy (Capecitabine) results in improved survival in these patients with non-pCR, although only about 15% of such patients do benefit. One of the most urgent unmet needs is to identify patients who will do well despite non-pCR (so as to avoid extra chemotherapy) and who will do poorly despite it, and also to identify factors of poor prognosis that may lead to novel therapeutic strategies in this group.

Current state of advancement of the technology: Until now, no biomarker except BRCA1/2 mutations has demonstrated clinical utility in the treatment of TNBC, likely due to the complex biology and heterogeneity of the disease. With the recent advances in Artificial Intelligence methodology, combining and integrating several layers of molecular data to predict outcome, until now challenging, becomes a reality. The hypothesize is that combining multi-dimensional data of tumor and plasma EVs can facilitate the development of prognostic and predictive signatures in this very aggressive disease.

Preliminary data: Thanks to our Q-CROC-03 biopsy driven clinical trial where tumor and plasma from patients with TNBC resistant to chemotherapy were collected. Whole exome seq data were translated to generate personalized circulating tumor DNA (ctDNA) assays. Our data shows a potential prognostic value to the detection of ctDNA after pre-operative chemotherapy. There is a collaboration established with Rodney Ouellette (ACRI) to isolate and profile extracellular vesicles (EVs) from plasma.

Objectives: The objective of the present study is to 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.

Experimental approach: EVs profiling from plasma collected in the Q-CROC-03 trial and the JGH biobank (prior, during and after chemotherapy treatment) will be performed. Profiling will include Whole Genome Sequencing (GWS), proteomics, transcriptomics and miRNA analysis. In collaboration with our industrial partner, My Intelligent Machines (MIMs), experts in bioinformatics and AI, machine-learning algorithms will be developed to integrate OMICs data from resistant tumors with matched plasma EVs data and generate a tumor/plasma signature associated with poor outcome. In parallel, in collaboration with the EXACTIS Innovation Network, patients recruitment, collection of residual tumors post chemotherapy and matched serial plasma samples during capecitabine treatment after surgery to perform the validation of the signature identified, the tumor/EV signature will be associated with patient survival.

Milestones of the proposed project: 1. Profiling of EVs from plasma. 2. Profiling of chemoresistant tumors 3. Development of algorithms to integrate multidimensional data from tumor and EVs.

The developed signatures will be IP protected. Academic and industrial partners will have shared IP (respective % to be determined). Prognostic tests will be developed on identified biomarkers and distributed through MIMsOmic Platform. MIMsOmic is an AI-powered platform commercialized by MIMs and enabling an easy, efficient and cost-effective delivery of clinical tests involving Omic data analysis.

The present project will develop a biomarker signature of poor prognosis for the most aggressive type of breast cancer. This signature will allow the identification of patients who should not be treated with post-surgery chemotherapy, and avoid unnecessary exposure to the toxicity associated with this drug.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • Recruiting
        • St. Joseph's Health Care London
        • Contact:
        • Sub-Investigator:
          • Muriel Brackstone, Dr
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • The Ottawa Hospital Cancer Center
        • Contact:
        • Sub-Investigator:
          • Terry Ng, Dr
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E1
        • Recruiting
        • Jewish General Hospital
        • Contact:
        • Principal Investigator:
          • Mark Basik, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jewish General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Exactis Innovation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark Basik, Dr, Study Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 5, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TRICIA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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