Evaluating Minimal Residual Disease (MRD) Through Longitudinal Circulating Tumor DNA (ctDN
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.
| Condition(s) | Breast Cancer, TNBC - Triple-Negative Breast Cancer, HR Positive/HER-2 Negative Breast Cancer, HER2 + Breast Cancer, Early Stage Breast Cancer |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Lead sponsor | Tempus AI |
| Locations | Birmingham, Alabama, United States; Whittier, California, United States; Weston, Florida, United States; Carbondale, Illinois, United States; O'Fallon, Illinois, United States; Goshen, Indiana, United States (+8 more sites) |
| Start date | 2025-10-27 |
| NCT ID | NCT07211178 |
| Official listing | https://clinicaltrials.gov/study/NCT07211178 |