An interventional study of Circulating tumor DNA in Breast Cancer and Lymph Node Metastasis, sponsored by UNC Lineberger Comprehensive Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by UNC Lineberger Comprehensive Cancer Center · Not applicable, Interventional, and Diagnostic
The purpose of this study is to determine how circulating tumor DNA (ctDNA), a sign of minimal residual disease (MRD), is detectable after surgery in patients with early HR+/HER2- breast cancer that has spread to 1-3 lymph nodes. Researchers aim to understand if ctDNA detection can identify patients at higher risk of recurrence and guide better treatment decisions. A key aspect is the inclusion of a dedicated cohort of African American/Black women, a group underrepresented in molecular residual disease (MRD) research despite experiencing more aggressive breast cancers. This study will correlate ctDNA results with treatment patterns (radiotherapy, systemic therapy) and outcomes (recurrence-free and overall survival) in both non-African American and African American participants.
Ultimately, the goal is to improve treatment strategies for this patient population. Detecting minimal residual disease (MRD) is a promising approach to identifying patients at increased risk of recurrence after definitive therapy, who may benefit from the escalation of their treatment and remain potentially curable with effective local and systemic therapy. Circulating tumor DNA (ctDNA), found in blood plasma, has recently emerged as a noninvasive approach for disease monitoring and detecting MRD through tracking tumor mutations. Nodal involvement is correlated with ctDNA positivity across multiple cancer types, and therefore, the use of ctDNA may capture patients who are more likely to have additional involvement of unresected axillary lymph nodes and can benefit from additional adjuvant therapies. One goal of this project is to investigate the clinical utility of using ctDNA as a biomarker to help tailor adjuvant radiation and systemic therapy in breast cancer (BC) patients with nodal disease, especially luminal subtype N1 BC, a group for which there is limited data available regarding the best treatment approach. As such, the primary objective of this study is to evaluate the prevalence of ctDNA-based MRD status in all patients by defining the proportion of patients with MRD-only recurrence post-operatively. Tumor tissue will be collected at surgery for genetic analysis. Blood samples for ctDNA testing will be taken at enrollment every three months. ctDNA results will be kept from treating physicians. Researchers will retrospectively analyze the relationship between ctDNA levels, administered treatments, and cancer recurrence.
A dedicated cohort of this study will enroll only African American/Black patients with early-stage, node-positive breast cancer of any subtype, who proceeded to surgery as their first treatment modality. The rationale for this cohort is to increase diversity in genomic research in Black populations, where more aggressive breast cancers are diagnosed, and non-invasive methods could provide novel insights for cancer treatment. There is a paucity of data on ctDNA prevalence and dynamics in Black patients with breast cancer, and this will be the first study of its kind to study ctDNA in Black patients. This study will provide information on ctDNA prevalence in early-stage breast cancer with 1-3 positive lymph nodes.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 100 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 414 studies on the registry; 96 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 25 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
In order to participate in this study, a subject must meet all of the eligibility criteria outlined below.
Inclusion Criteria:
Exclusion Criteria:
50 Non-African American participants with lymph node-positive (1-3 LNs) early breast cancer (all subtypes).
Diagnostic Test: Circulating tumor DNA
50 African American participants with lymph node-positive (1-3 LNs) early breast cancer (all subtypes).
Diagnostic Test: Circulating tumor DNA
Circulating tumor DNA (ctDNA) is a noninvasive prognostic biomarker for disease monitoring. ). Blood collection for ctDNA testing will be performed at the time of enrollment (prior to initiation of adjuvant therapy), and every three months thereafter.
Number of participants have post-operative circulating tumor DNA (ctDNA) positive
Circulating tumor DNA (ctDNA) will be tested and a number of participants who were tested for positive ctDNA status. Post-operative ctDNA status will be categorized as either detectable or undetectable.
Time frame: Baseline
Number of participants have circulating tumor DNA (ctDNA) positive in Cohort 1
Circulating tumor DNA (ctDNA) will be tested and a number of participants who were tested for positive ctDNA status. ctDNA status will be categorized as either detectable or undetectable in Cohort1.
Time frame: Baseline
Number of participants have circulating tumor DNA (ctDNA) positive in Cohort 2
Circulating tumor DNA (ctDNA) will be tested and a number of participants who were tested for positive ctDNA status. ctDNA status will be categorized as either detectable or undetectable in Cohort2.
Time frame: Baseline
Number of participants have circulating tumor DNA (ctDNA) positive at 12 months
Circulating tumor DNA (ctDNA) will be tested at 12 month and a number of participants who were tested for positive ctDNA status. ctDNA status will be categorized as either detectable or undetectable at 12 months from the time of surgery, vs otherwise in cohorts 1 and 2.
Time frame: 12 months
ctDNA clearance after systemic adjuvant chemotherapy in cohorts 1 and 2
ctDNA clearance after systemic adjuvant chemotherapy in cohorts 1 and 2 participants with ctDNA positivity post-operatively will be defined as the proportion of participants who convert from ctDNA positive to negative after completion of adjuvant chemotherapy if indicated.
Time frame: Up to 6 months
ctDNA clearance after adjuvant radiation therapy in cohorts 1 and 2
ctDNA clearance after adjuvant radiation therapy in cohorts 1 and 2 participants with ctDNA positivity post-operatively will be defined as the proportion of participants who convert from ctDNA positive to negative after completion of adjuvant radiation therapy, if indicated.
Time frame: Up to 12 months
Recurrence-free survival
Recurrence-free survival, defined as the time from surgery to when there is evidence of cancer recurrence, will be calculated for cohorts 1 and 2.
Time frame: Up to 12 months
Overall survival
Overall survival, defined as the time from surgery to the time of death, will be calculated for cohorts 1 and 2.
Time frame: Up to 12 months
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
UNC Lineberger Comprehensive Cancer Center