RecruitingNot ApplicableNCT07025785

Molecular Residual Disease Assessment in a Representative Diverse Population of Patients With Early-stage Breast Cancer


Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

100 participants

Start Date

Aug 22, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a blood test (circulating tumor DNA, or ctDNA) that detects tiny traces of cancer remaining after surgery in a diverse group of patients with early-stage breast cancer, to see how well it predicts cancer recurrence. **You may be eligible if...** - You are 18 or older - You have had surgery for early-stage breast cancer - Tissue from your tumor or lymph nodes is available from the surgery for ctDNA testing - You are willing to comply with study procedures **You may NOT be eligible if...** - You received chemotherapy or hormone therapy before surgery (neoadjuvant therapy) - Imaging has shown evidence of cancer spread (metastatic disease) - You only have very small isolated cancer cells found in lymph nodes (called N1 mic or isolated tumor cells) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTCirculating 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.


Locations(1)

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

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NCT07025785


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