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AI blood test could spare some breast cancer patients extra chemo

NCT ID NCT04874064

Knowledge-focused Sponsor: Jewish General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aims to develop a blood test that uses artificial intelligence to analyze tumor material in the blood of people with triple negative breast cancer. The goal is to better predict which patients need more chemotherapy after surgery and which can safely avoid it. Researchers will collect blood and tissue samples from 130 participants to build a test that guides treatment decisions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 130 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2019

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Jewish General Hospital

    RECRUITING

    Montreal, Quebec, H3T 1E1, Canada

  • St. Joseph's Health Care London

    RECRUITING

    London, Ontario, N6A 4V2, Canada

  • The Ottawa Hospital Cancer Center

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

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