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

UNC Lineberger Comprehensive Cancer Center · with Haystack Oncology, Inc. · NCT07025785

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
100
US sites recruiting
1
Study start
August 22, 2025
Record last updated
September 2, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Circulating tumor DNA

Conditions: Breast Cancer; Lymph Node Metastasis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Recruiting US locations

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, NC 27514

    Site contact: Taylor Pierce · 919-984-0000 · Taylor_Pierce@med.unc.edu

Study contacts (from the official record)

  • Taylor Pierce · 919-445-4872 · Taylor_Pierce@med.unc.edu
All healthy volunteers studies in North Carolina →
Molecular Residual Disease Assessment in a Representative Diverse… (NCT07025785) | Bored Studies