NCT07025785 Molecular Residual Disease Assessment in a Representative Diverse Population of Patients With Early-stage Breast Cancer
| NCT ID | NCT07025785 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UNC Lineberger Comprehensive Cancer Center |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-08-22 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-08-22 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Yara Abdou, MD
PRINCIPAL INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT07025785 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07025785 currently recruiting?
Yes, NCT07025785 is actively recruiting participants. Contact the research team at timothy_wilkinson@med.unc.edu for enrollment information.
Where is the NCT07025785 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT07025785 clinical trial?
NCT07025785 is sponsored by UNC Lineberger Comprehensive Cancer Center. The principal investigator is Yara Abdou, MD at UNC Lineberger Comprehensive Cancer Center. The trial plans to enroll 100 participants.
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