Recruiting

ctDNA

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT07025785

Conditions

Breast Cancer

Lymph Node Metastasis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Circulating tumor DNA

Study Details

Brief 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. 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.

Conditions

Breast Cancer

Lymph Node Metastasis

Study ID

NCT07025785

Start date

Aug 22, 2025

Status verified date

Sep, 2026

Completion date

Sep 1, 2031

Anticipated

Primary completion date

Sep 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

In order to participate in this study, a subject must meet all of the eligibility criteria outlined below.

Inclusion Criteria:

1. Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
2. Subjects are willing and able to comply with study procedures based on the judgment of the investigator.
3. Age ≥ 18 years at time of consent.
4. 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.

Exclusion Criteria:

1. Subjects must not have had prior neoadjuvant therapy.
2. Evidence of metastatic disease in imaging.
3. N1 mic or isolated tumor cells in the lymph nodes

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 1:Non African American

50 Non-African American participants with lymph node-positive (1-3 LNs) early breast cancer (all subtypes).

experimental: 2: African American

50 African American participants with lymph node-positive (1-3 LNs) early breast cancer (all subtypes).

Interventions

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.

Primary outcome measure

  • Number of participants have post-operative circulating tumor DNA (ctDNA) positive [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Taylor Pierce

919-445-4872Taylor_Pierce@med.unc.edu

Locations

UNC Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Taylor Pierce

919-984-0000Taylor_Pierce@med.unc.edu

Paige Stem

paige_stem@med.unc.edu

Principal Investigator:

Yara Abdou, MD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Sep 2, 2026

Last verified

Sep, 2026

Keywords

  • circulating tumor DNA (ctDNA)
  • minimal residual disease (MRD)
  • African American

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-09-02.