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

NCT07025785 | Recruiting DMC

• 1 other identifier: LCCC2412-DCT
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of participants have post-operative circulating tumor DNA (ctDNA) positive

  Circulating tumor DNA (ctDNA) will be tested and a number of participants who were tested for positive ctDNA status. Post-operative ctDNA status will be categorized as either detectable or undetectable.

  Baseline

Secondary Outcomes (1)

• Number of participants have circulating tumor DNA (ctDNA) positive in Cohort 1

  Baseline

Other Outcomes (6)

• Number of participants have circulating tumor DNA (ctDNA) positive in Cohort 2

  Baseline

• Number of participants have circulating tumor DNA (ctDNA) positive at 12 months

  12 months

• ctDNA clearance after systemic adjuvant chemotherapy in cohorts 1 and 2

  Up to 6 months

Study Arms (2)

1:Non African American

EXPERIMENTAL

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

Diagnostic Test: Circulating tumor DNA

2: African American

EXPERIMENTAL

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

Diagnostic Test: Circulating tumor DNA

Interventions

Circulating tumor DNA DIAGNOSTIC_TEST

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.

1:Non African American; 2: African American

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Haystack Oncology, Inc.: collaborator
• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Related Links

• UNC Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms; Lymphatic Metastasis; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yara Abdou, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy H Wilkinson

CONTACT

919-445-4872; timothy_wilkinson@med.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 17, 2025
• Study Start: August 22, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)