Recruiting

Observational Study

Sponsor:

Jewish General Hospital

Code:

NCT04874064

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Liquid Biopsy

Study Details

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

Study ID

NCT04874064

Start date

Dec 5, 2019

Status verified date

Nov, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

130 participants

Anticipated

Interventions and Outcome Measures

Interventions

Liquid Biopsy

Blood collection and access to residual tumor.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Adriana Aguilar, PhD

514-340-8222nanaaguilar@gmail.com

Josiane Lafleur, MSc

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

Locations

St. Joseph's Health Care London

Recruiting

London, Ontario, Canada, N6A 4V2

Contacts

Kalan S. Lynn, MSc

519-646-6100kalan.lynn@lhsc.on.ca

The Ottawa Hospital Cancer Center

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Nathalie Tremblay

613-737-7700natremblay@ohri.ca

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E1

Contacts

Josiane Lafleur

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

Principal Investigator:

Mark Basik, Dr

More Information

Sponsor

Jewish General Hospital

Last update posted

Nov 28, 2025

Last verified

Nov, 2025

Keywords

  • Breast Cancer
  • Liquid Biopsy
  • Artificial Intelligence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jewish General Hospital on 2025-11-28.