Finding tiny amounts of tumor DNA in the blood after surgery for early HR+/HER2- breast cancer with 1–3 positive lymph nodes
Official title: Molecular Residual Disease Assessment in a Representative Diverse Population of Patients With Early-stage Breast Cancer
Run by UNC Lineberger Comprehensive Cancer Center · NCT07025785 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Status | Recruiting |
| Started | August 22, 2025 |
| Main results expected | September 1, 2030 |
| Study ends | September 1, 2031 |
| Registry record updated | September 2, 2026 |
| Trial ID | NCT07025785 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
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: Taylor Pierce
- Email: Taylor_Pierce@med.unc.edu
- Phone: 919-445-4872
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Gyrotonic exercise for elders with breast cancer and Behcet disease
We’re testing whether a gyrotonic exercise program helps older people who have both Behcet disease and breast cancer.
-
PECS II vs SPSIP nerve blocks for pain after mastectomy
This study tests whether two ultrasound-guided nerve blocks (PECS II and SPSIP) differ in how much opioid patients need after mastectomy.
-
CG-7321: a first-in-human test in advanced solid tumors
We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.
-
Compare a new endoscopy-assisted breast-conserving surgery with the usual approach
This study tests whether a new endoscopy-assisted breast-conserving technique can provide similar or better cosmetic outcomes and safety compared with conventional breast-conserving surgery in women with early breast cancer who want to preserve their breast.
-
Different skin care approaches to prevent skin reactions after mastectomy radiation
This study tests three standard skin care methods to see which best prevents radiation dermatitis in people who had a mastectomy and are receiving post-mastectomy radiation therapy.
-
3D Heart Strain to Detect Early Cardiotoxicity in Cancer Therapy
This study tests whether 3D echocardiography can detect early heart damage from cancer treatments like anthracyclines or HER2-targeted therapy better than standard 2D methods.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.