Evaluating Minimal Residual Disease (MRD) Through Longitudinal Circulating Tumor DNA (ctDNA) Prof… (NCT07211178) | Clinical Trial Compass
RecruitingNot Applicable
Evaluating Minimal Residual Disease (MRD) Through Longitudinal Circulating Tumor DNA (ctDNA) Profiling in Breast Malignancies
United States900 participantsStarted 2025-10-27
Plain-language summary
For patients with breast cancer, it's important to find any remaining cancer cells after they've had their main treatment. Even a few cells, called minimal residual disease (MRD), can lead to the cancer coming back later.
A way to find these cells is by looking for tiny bits of cancer DNA that are shed into the blood. This is called circulating tumor DNA (ctDNA). A simple blood test, often called a liquid biopsy, can detect this ctDNA. This research aims to see if finding this cancer DNA in the blood can help predict if a patient's cancer will return. It also may help find out if the treatment is working.
Ultimately, the results of this research may help doctors better manage breast cancer and develop new and improved tests and treatments.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Willing and able to participate in the research and provide biospecimens
. Willing and able to provide informed consent
. Must be diagnosed with breast cancer
. A known or suspected HR+, HER2- breast cancer treated with curative intent (Stage II to III disease)
. Patients are considered at high risk of recurrence, defined as 4 or more positive axillary lymph nodes (ALNs), or between 1-3 positive ALNs and either grade 3 disease or tumor size of 5 cm or larger.
. A known or suspected HR+, HER2- breast cancer treated with curative intent (Stage II to III disease)
. Patients are considered at high risk of recurrence, defined as 4 or more positive axillary lymph nodes (ALNs), or between 1-3 positive ALNs and either grade 3 disease or tumor size of 5 cm or larger.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses ctDNA blood tests to detect minimal residual disease across different points in my treatment — during chemotherapy before surgery, right after surgery, and then during long-term follow-up — so how would knowing my MRD status at each of those stages actually change the decisions my care team makes about my treatment?
2Since this study is observational and focused on measuring ctDNA to track disease-free survival rather than testing a new drug or procedure, does participating mean I'd be receiving any different treatment than I would outside the trial, or would I mainly be providing additional blood samples?
3This trial covers several breast cancer subtypes including triple-negative, HER2-positive, and HR-positive/HER2-negative — given my specific subtype, is ctDNA monitoring considered more or less informative for detecting residual disease in my case compared to other subtypes?
4The trial is measuring invasive disease-free survival stratified by MRD status over a long follow-up period, which suggests this is a multi-year commitment — what would the time, visit, and blood draw schedule actually look like for me, and how might that fit with my current treatment plan?
5If my ctDNA results during this study show signs of minimal residual disease, would that finding be shared with me and my care team in real time, and could it lead to changes in my treatment, or would the results only be analyzed after the study is complete?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Invasive Disease-Free Survival (iDFS) stratified by MRD status during neoadjuvant, post-surgery landmark, post definitive treatment (surveillance), and long-term follow-up
. Have undergone curative intent surgery with no clinical evidence of disease.
Exclusion criteria
. Not willing or able to adhere with the study procedures
. Active secondary malignancy
. Diagnosis of a malignancy within 3 years of breast cancer diagnosis Note: Ductal carcinoma in situ (DCIS, ipsilateral or contralateral) within 3 years is not excluded.