Breast CancerNCT07025785
Molecular Residual Disease Assessment in a Representative Diverse Population of Patients With Early-stage Breast Cancer
A study testing Circulating tumor DNA in people with Breast Cancer and Lymph Node Metastasis, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Lymph Node Metastasis
- What is being tested?
- Circulating tumor DNA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2025to 1 Sep 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Subjects are willing and able to comply with study procedures based on the judgment of the investigator.
- Age ≥ 18 years at time of consent.
- Subject must have had surgical intervention and must have sufficient archival specimens from either the primary tumor or a lymph node for ctDNA assay development, as specified in the lab manual.
Who cannot join
- Subjects must not have had prior neoadjuvant therapy.
- Evidence of metastatic disease in imaging.
- N1 mic or isolated tumor cells in the lymph nodes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514
Taylor Pierce, 919-984-0000, Taylor_Pierce@med.unc.edu
Paige Stem, paige_stem@med.unc.edu
About this study
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.
Read the detailed description
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.
- Conditions
- Breast Cancer, Lymph Node Metastasis
- Being tested
- Circulating tumor DNA
- Keywords
- circulating tumor DNA (ctDNA), minimal residual disease (MRD), African American
- Medical subject headings
- Breast Neoplasms, Lymphatic Metastasis, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulating tumor DNADiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 1:Non African American | Experimental | 50 Non-African American participants with lymph node-positive (1-3 LNs) early breast cancer (all subtypes). Receives: Diagnostic Test: Circulating tumor DNA |
| 2: African American | Experimental | 50 African American participants with lymph node-positive (1-3 LNs) early breast cancer (all subtypes). Receives: Diagnostic Test: Circulating tumor DNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (1)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start22 Aug 2025
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Haystack Oncology, Inc.
- Responsible party
- Sponsor
- Investigators
- Yara Abdou, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025785
- Sponsor's protocol ID
- LCCC2412-DCT
- Status last verified
- Sep 2026
- First submitted
- 9 Jun 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Residual Disease Assessment in a Representative Diverse Population of Patients With Early-stage Breast Cancer
- ClinicalTrials.gov ID
- NCT07025785
- Acronym / sponsor ID
- LCCC2412-DCT
- Conditions
- Breast Cancer, Lymph Node Metastasis
- Keywords
- circulating tumor DNA (ctDNA), minimal residual disease (MRD), African American
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Haystack Oncology, Inc.
- Study start
- 22 Aug 2025 (actual)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1:Non African American | Experimental | Diagnostic Test: Circulating tumor DNA50 Non-African American participants with lymph node-positive (1-3 LNs) early breast cancer (all subtypes). |
| 2: African American | Experimental | Diagnostic Test: Circulating tumor DNA50 African American participants with lymph node-positive (1-3 LNs) early breast cancer (all subtypes). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Subjects are willing and able to comply with study procedures based on the judgment of the investigator.
- Age ≥ 18 years at time of consent.
- Subject must have had surgical intervention and must have sufficient archival specimens from either the primary tumor or a lymph node for ctDNA assay development, as specified in the lab manual.
Key exclusion criteria (3 listed)
- Subjects must not have had prior neoadjuvant therapy.
- Evidence of metastatic disease in imaging.
- N1 mic or isolated tumor cells in the lymph nodes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circulating tumor DNACirculating 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. | Diagnostic test | 1:Non African American, 2: African American |
Primary outcome
Number of participants have post-operative circulating tumor DNA (ctDNA) positive
Time frame: Baseline
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.
1 secondary outcome
Number of participants have circulating tumor DNA (ctDNA) positive in Cohort 1
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- UNC Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yara Abdou, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circulating tumor DNA in people with Breast Cancer and Lymph Node Metastasis, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taylor Pierce (919-445-4872, Taylor_Pierce@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants have post-operative circulating tumor DNA (ctDNA) positive (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.