Back to Trials
NCT07211178Recruiting

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

Tempus AI

Start Date

10/27/2025

Completion Date

12/1/2033

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 Criteria

Age Range: 18 years to 99 years

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.

Interventions

OTHER

There are no interventions in this observational study.

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Breast CancerTNBC - Triple-Negative Breast CancerHR Positive/HER-2 Negative Breast CancerHER2 + Breast CancerEarly Stage Breast Cancer

Locations

Birmingham Hematology Associates

Birmingham, Alabama 35223

United States

PIH Health Whittier Hospital

Whittier, California 90602

United States

Cleveland Clinic Florida

Weston, Florida 33331

United States

Southern Illinois Hospital Services

Carbondale, Illinois 62902

United States

Cancer Care Specialist of Illinois

O'Fallon, Illinois 62269

United States

Goshen Center for Cancer Care

Goshen, Indiana 46526

United States

Trinity Health

Ann Arbor, Michigan 48106

United States

Oncology Hematology Associates

Springfield, Missouri 65807

United States

Cancer Care Specialist of Reno

Reno, Nevada 89511

United States

Summit Medical Group

Florham Park, New Jersey 07932

United States

University of Cincinnati Medical Center

Cincinnati, Ohio 45219

United States

Nashville General

Nashville, Tennessee 37208

United States

Cancer Care Northwest

Spokane Valley, Washington 99216

United States

Gunderson Health

La Crosse, Wisconsin 54601

United States