TRIple Negative Breast Cancer Markers In Liquid Biopsies Using Artificial Intelligence

ConditionBreast Cancer

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorJewish General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Liquid Biopsy
Other intervention
Blood collection and access to residual tumor.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jewish General Hospital

Lead sponsor

Exactis Innovation

Collaborator

Source ClinicalTrials.gov

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