Actively Recruiting
Molecular Residual Disease Assessment in a Representative Diverse Population of Patients With Early-stage Breast Cancer
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2026-01-15
100
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
Sponsors
U
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
H
Haystack Oncology, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Molecular Residual Disease Assessment in a Representative Diverse Population of Patients With Early-stage Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent and HIPAA authorization obtained
- Willing and able to follow study procedures as judged by the investigator
- Age 18 years or older at time of consent
- Had surgery and have enough tumor or lymph node tissue for ctDNA testing as per lab manual
You will not qualify if you...
- Prior neoadjuvant therapy
- Evidence of metastatic disease on imaging
- Presence of N1 micrometastases or isolated tumor cells in lymph nodes
AI-Screening
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Trial Site Locations
Total: 1 location
1
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
Research Team
T
Timothy H Wilkinson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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