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Clinical Trials in the USA / NCT07211178
Recruiting Observational

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

NCT07211178 · tracked via the Priya Life Science USA tracker
Sponsor
Tempus AI
Phase
Observational
Started
2025-10-27
Last updated
2026-09-03

Condition(s) studied

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

Investigational drug(s) / intervention(s)

There are no interventions in this observational study.

There are no interventions in this observational study.: There are no interventions in this observational study.

Study 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

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (16)

FacilityCityRegionStatus
Birmingham Hematology Associates Birmingham Alabama Recruiting
PIH Health Whittier Hospital Whittier California Recruiting
Cleveland Clinic Florida Weston Florida Recruiting
Southern Illinois Hospital Services Carbondale Illinois Recruiting
Cancer Care Specialist of Illinois O'Fallon Illinois Recruiting
Goshen Center for Cancer Care Goshen Indiana Recruiting
Trinity Health Ann Arbor Michigan Recruiting
Oncology Hematology Associates Springfield Missouri Recruiting
Cancer Care Specialist of Reno Reno Nevada Recruiting
Summit Medical Group Florham Park New Jersey Recruiting
University of Cincinnati Medical Center Cincinnati Ohio Recruiting
Sanford - Sioux Falls Sioux Falls South Dakota Recruiting
Nashville General Nashville Tennessee Recruiting
UT Health Houston Houston Texas Recruiting
Cancer Care Northwest Spokane Valley Washington Recruiting
Gunderson Health La Crosse Wisconsin Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07211178 on ClinicalTrials.gov ↗ ← All trials in the USA