RecruitingNCT07211178

Evaluating Minimal Residual Disease (MRD) Through Longitudinal Circulating Tumor DNA (ctDNA) Profiling in Breast Malignancies


Sponsor

Tempus AI

Enrollment

900 participants

Start Date

Oct 27, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

For patients with breast cancer, it's important to find any remaining cancer cells after they've had their main treatment. Even a few cells, called minimal residual disease (MRD), can lead to the cancer coming back later. A way to find these cells is by looking for tiny bits of cancer DNA that are shed into the blood. This is called circulating tumor DNA (ctDNA). A simple blood test, often called a liquid biopsy, can detect this ctDNA. This research aims to see if finding this cancer DNA in the blood can help predict if a patient's cancer will return. It also may help find out if the treatment is working. Ultimately, the results of this research may help doctors better manage breast cancer and develop new and improved tests and treatments.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study tracks tiny fragments of tumor DNA circulating in the blood (called ctDNA) over time in breast cancer patients. It aims to detect whether cancer is lingering after treatment even when standard scans look clear — helping identify who needs more aggressive therapy. **You may be eligible if...** - You have been diagnosed with breast cancer (any subtype) - You are willing to provide blood samples over time - For the high-risk HR+/HER2- group: you have Stage II–III disease with 4 or more positive lymph nodes, or 1–3 positive nodes plus grade 3 disease or a tumor 5 cm or larger - For the HER2+ group: Stage II–III disease treated with curative intent - For the triple-negative group: Stage II–III disease treated with curative intent **You may NOT be eligible if...** - You are not willing or able to provide blood samples - You are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERThere are no interventions in this observational study.

There are no interventions in this observational study.


Locations(12)

Birmingham Hematology Associates

Birmingham, Alabama, United States

PIH Health Whittier Hospital

Whittier, California, United States

Southern Illinois Hospital Services

Carbondale, Illinois, United States

Cancer Care Specialist of Illinois

O'Fallon, Illinois, United States

Goshen Center for Cancer Care

Goshen, Indiana, United States

Trinity Health

Ann Arbor, Michigan, United States

Oncology Hematology Associates

Springfield, Missouri, United States

Cancer Care Specialist of Reno

Reno, Nevada, United States

Summit Medical Group

Florham Park, New Jersey, United States

Nashville General

Nashville, Tennessee, United States

Cancer Care Northwest

Spokane Valley, Washington, United States

Gunderson Health

La Crosse, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT07211178


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