Evaluating Minimal Residual Disease (MRD) Through Longitudinal Circulating Tumor DNA (ctDNA) Profiling in Breast Malignancies
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…
Breast Cancer, TNBC - Triple-Negative Breast Cancer, HR Positive/HER-2 Negative Breast Cancer, HER2 + Breast Cancer, Early Stage Breast Cancer
About this study
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.
Interventions
Other: There are no interventions in this observational study. — There are no interventions in this observational study.
Primary outcomes
Invasive Disease-Free Survival (iDFS) stratified by MRD status during neoadjuvant, post-surgery landmark, post definitive treatment (surveillance), and long-term follow-up (5 years)
Eligibility information
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.
Study 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
Showing 10 of 16 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-20.