Finding tiny amounts of tumor DNA in the blood after surgery for early HR+/HER2- breast cancer with 1–3 positive lymph nodes

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

This project tests whether a blood test that finds tiny bits of tumor DNA after surgery can identify people with early HR+/HER2- breast cancer and 1–3 positive lymph nodes who are more likely to have the cancer come back, including a dedicated group of African American women.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: UNC Lineberger Comprehensive Cancer Center (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Chapel Hill, North Carolina)
• Trial ID: NCT07025785 on ClinicalTrials.gov

What this trial studies

This interventional study collects tumor tissue at surgery and takes blood every three months to look for circulating tumor DNA (ctDNA) as a sign of minimal residual disease (MRD). The trial focuses on patients with early HR+/HER2- breast cancer and 1–3 involved lymph nodes who did not receive neoadjuvant therapy. Researchers will correlate ctDNA results with treatments given (radiation and systemic therapy) and with outcomes such as recurrence-free and overall survival. A specific cohort of African American/Black participants is included to address underrepresentation and examine MRD prevalence and outcomes in this population.

Who should consider this trial

Good fit: Adults (≥18 years) with early HR+/HER2- breast cancer who had surgery, have 1–3 positive lymph nodes, available tumor tissue for testing, and can attend regular blood draws are ideal candidates.

Not a fit: Patients who had prior neoadjuvant therapy, have evidence of metastatic disease, only micrometastases or isolated tumor cells in nodes, or those with disease subtypes outside HR+/HER2- are unlikely to benefit from this particular protocol.

Why it matters

Potential benefit: If successful, using ctDNA to detect MRD could help personalize adjuvant treatment by identifying patients who may benefit from treatment escalation to reduce risk of recurrence.

How similar studies have performed: Prior research in several cancers and emerging breast cancer cohorts has shown that ctDNA-based MRD can predict recurrence, but its clinical use to guide adjuvant therapy is still being validated.

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

Where this trial is running

Chapel Hill, North Carolina

• UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States (Recruiting)

Study contacts

• Principal investigator: Yara Abdou, MD — UNC Lineberger Comprehensive Cancer Center
• Study coordinator: Timothy H Wilkinson

Conditions Breast Cancer; Lymph Node Metastasis; circulating tumor DNA; minimal residual disease; African American