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Simple blood test could predict breast cancer return

NCT ID NCT07211178

Knowledge-focused Sponsor: Tempus AI 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Updated 2 times

Summary

This study is looking at whether a simple blood test can find tiny bits of cancer DNA left in the body after breast cancer treatment. These leftover cells, called minimal residual disease (MRD), can sometimes cause the cancer to come back. The study will follow 900 breast cancer patients over time to see if the test results can predict recurrence and help doctors make better treatment decisions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors better predict if breast cancer will return and guide more personalized follow-up care.
What could go wrong
This is an observational study, not testing a treatment. It may not directly improve outcomes, and results may take years to apply in practice.

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 900 people

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

Started

Oct 2025

Expected to finish

Dec 2033

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

The population of this study includes early stage breast cancer patients with triple negative breast cancer (Stages I to III), HER2 positive (Stages II and III), and high risk HR positive HER-2 negative (Stages II and III).

Ages

18 to 99 years

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: All Cohorts: 1. Willing and able to participate in the research and provide biospecimens 2. Willing and able to provide informed consent 3. Must be diagnosed with breast cancer Cohort 1: Neoadjuvant Treatment Cohort 1A: Newly Diagnosed, High Risk HR+,HER2- 1. A known or suspected HR+, HER2- breast cancer treated with curative intent (Stage II to III disease) 2. Patients are considered at high risk of recurrence, defined as 4 or more positive axillary lymph nodes (ALNs), or between 1-3 positive ALNs and either grade 3 disease or tumor size of 5 cm or larger. Cohort 1B: HER2+ 1. A known or suspected HER2+ breast cancer treated with curative intent (Stage II to III disease). Inclusive of HR+ or HR- patients. Cohort 1C: Triple Negative Breast Cancer 1\. A known or suspected triple negative breast cancer treated with curative intent (Stage I to III disease). Cohort 2: Adjuvant Therapy / Surveillance Cohort 2A: Newly Diagnosed HR+,HER2- 1. A known or suspected HR+, HER2- breast cancer treated with curative intent (Stage II to III disease) 2. Patients are considered at high risk of recurrence, defined as 4 or more positive axillary lymph nodes (ALNs), or between 1-3 positive ALNs and either grade 3 disease or tumor size of 5 cm or larger. 3. Have undergone curative intent surgery with no clinical evidence of disease. Cohort 2B: HER2+ 1. A known or suspected HER2+ breast cancer treated with curative intent (Stage II to III disease) 2. Have undergone curative intent surgery with no clinical evidence of disease. Cohort 2C: Triple Negative Breast Cancer 1. A known or suspected triple negative breast cancer treated with curative intent (Stage I to III disease) 2. Have undergone curative intent surgery with no clinical evidence of disease. Cohort 3: 5-Years Post-Diagnosis Surveillance (NED) 1. A known HR+, HER2- breast cancer treated with curative intent (Stage II to III disease). 2. No Evidence of Disease (NED) ≥ 5 years from initial diagnosis. 3. Patients are considered at high risk of recurrence, defined as 4 or more positive axillary lymph nodes (ALNs), or between 1-3 positive ALNs and either grade 3 disease or tumor size of 5 cm or larger. Exclusion Criteria: 1. Not willing or able to adhere with the study procedures 2. Active secondary malignancy 3. Diagnosis of a malignancy within 3 years of breast cancer diagnosis Note: Ductal carcinoma in situ (DCIS, ipsilateral or contralateral) within 3 years is not excluded.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma hormone receptor-positive breast cancer Neoplasm, Residual triple-negative breast carcinoma

As listed by the trial registrant

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

Breast cancer Early-stage breast cancer HER2 + breast cancer HR positive/HER-2 negative breast cancer TNBC - triple-negative 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

    16 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

  • Birmingham Hematology Associates

    RECRUITING

    Birmingham, Alabama, 35223, United States

  • Cancer Care Northwest

    RECRUITING

    Spokane Valley, Washington, 99216, United States

  • Cancer Care Specialist of Illinois

    RECRUITING

    O'Fallon, Illinois, 62269, United States

  • Cancer Care Specialist of Reno

    RECRUITING

    Reno, Nevada, 89511, United States

  • Cleveland Clinic Florida

    RECRUITING

    Weston, Florida, 33331, United States

  • Goshen Center for Cancer Care

    RECRUITING

    Goshen, Indiana, 46526, United States

  • Gunderson Health

    RECRUITING

    La Crosse, Wisconsin, 54601, United States

  • Nashville General

    RECRUITING

    Nashville, Tennessee, 37208, United States

  • Oncology Hematology Associates

    RECRUITING

    Springfield, Missouri, 65807, United States

  • PIH Health Whittier Hospital

    RECRUITING

    Whittier, California, 90602, United States

  • Sanford - Sioux Falls

    RECRUITING

    Sioux Falls, South Dakota, 57401, United States

  • Southern Illinois Hospital Services

    RECRUITING

    Carbondale, Illinois, 62902, United States

  • Summit Medical Group

    RECRUITING

    Florham Park, New Jersey, 07932, United States

  • Trinity Health

    RECRUITING

    Ann Arbor, Michigan, 48106, United States

  • UT Health Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Cincinnati Medical Center

    RECRUITING

    Cincinnati, Ohio, 45219, United States

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