An observational study in Breast Cancer, sponsored by Jewish General Hospital. Recruiting at 3 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-28.
Sponsored by Jewish General Hospital · Observational
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.
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 130 is below the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood collection and access to residual tumor.
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
Plan to share: No
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