Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
EXActDNA-003 / NSABP B-64: Study of Molecular Residual Disease Detection in Breast Cancer (MRD)
NCT06401421 · View on ClinicalTrials.gov ↗
Study Summary
The EXActDNA-003 study will prospectively enroll participants who are planning to undergo chemotherapy for high-risk, early breast cancer, who are willing to provide tissue and blood specimens for circulating tumor DNA (ctDNA) analysis. Participants will be followed for up to 5.5 years.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST ctDNA MRD test
Study Locations (20)
Maryland
- Weinberg Center at Mercy — Baltimore
- Greater Baltimore Medical Center — Baltimore
- Sinai Hospital of Baltimore — Baltimore
- MedStar Georgetown Cancer Institute — Baltimore
- The Center for Cancer and Blood Disorders - Bethesda — Bethesda
Florida
- AdventHealth East Altamonte Oncology and Hematology — Altamonte Springs
- Mount Sinai Medical - Comprehensive Cancer Center — Miami Beach
- Baptist Cancer Care - Plantation — Plantation
- St. Joseph's Women's Hospital — Tampa
California
- Stanford Cancer Institute — Palo Alto
- Harbor-UCLA Medical Center - Hematology / Oncology — Torrance
- Kaiser Permanente Medical Center — Vallejo
Kentucky
- St. Elizabeth Edgewood Hospital — Edgewood
- Norton Cancer Institute - Downtown — Louisville
- Baptist Health Louisville — Louisville
Alaska
- Katmai Oncology Group - Anchorage — Anchorage
Colorado
- UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center — Aurora
Illinois
- Rush Cancer Center — Chicago
Indiana
- Deaconess Chancellor Center for Oncology — Newburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,800 participants |
| Start Date | 2024-06-07 |
| Est. Completion | 2030-04 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06401421
The ClinicalTrials.gov registry entry for NCT06401421 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,800 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Exact Sciences Corporation, which has 42 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention — of which ctDNA MRD test is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06401421 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Maryland, Florida, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06401421 about?
NCT06401421 is a clinical study titled "EXActDNA-003 / NSABP B-64: Study of Molecular Residual Disease Detection in Breast Cancer (MRD)". The EXActDNA-003 study will prospectively enroll participants who are planning to undergo chemotherapy for high-risk, early breast cancer, who are willing to provide tissue and blood specimens for circulating tumor DNA (ctDNA) analysis. Participants will be followed for up to 5.5 years.
What is the current status of trial NCT06401421?
This trial is currently recruiting. The enrollment target is 1,800 participants. The study started on 2024-06-07. Estimated completion is 2030-04.
What conditions does trial NCT06401421 study?
This clinical trial studies the following conditions: Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06401421?
The interventions under investigation include: ctDNA MRD test (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06401421?
This trial is sponsored by Exact Sciences Corporation, which has 42 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06401421 being conducted?
This trial has 20 study locations across Alaska, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.