Molecular Residual Disease Assessment in a Representative Diverse Population of Patients With Early-stage Breast Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Blood samples for ctDNA testing will be taken at enrollment every three months. ctDNA results will be kept from treating physicians."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks for tiny pieces of cancer DNA in the blood after surgery to see if they can help predict whether breast cancer will come back. It is for adults with early breast cancer that uses hormones to grow (HR+), is HER2-negative, and has spread to 1–3 lymph nodes. The study includes a group of African American/Black women to help address gaps in research.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Give written consent to join and allow the use of personal health information.
- Be willing and able to follow study steps, as judged by the study doctor.
- Be at least 18 years old when giving consent.
- Have had surgery and have enough stored tissue from the breast tumor or a lymph node to create the cancer DNA test.
Who can't join
- Had cancer treatment before surgery.
- Have scans showing cancer has spread to distant parts of the body.
- Have only very small cancer deposits (N1 mic) or single cancer cells in the lymph nodes.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (1)
NC
- UNC Lineberger Comprehensive Cancer Center · Chapel Hill, NC 27514Taylor Pierce · Study contact · 919-984-0000 · Taylor_Pierce@med.unc.eduPaige Stem · Study contact · paige_stem@med.unc.eduYara Abdou, MD · Principal investigatorMore trials in Chapel Hill