🏛️ Verified NIH Record • Updated 2026-01-16
EXActDNA-003 / NSABP B-64: Study of Molecular Residual Disease Detection in Breast Cancer (MRD) (NCT06401421)
🟢 Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Exact Sciences Corporation
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (12 items) and avoid the listed exclusions (10 items).
Location: Katmai Oncology Group - Anchorage — Anchorage, Alaska
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Definitive clinical or radiologic evidence of metastatic disease.
- Initiated neoadjuvant therapy for current breast cancer diagnosis.
- Synchronous diagnosis of another invasive cancer, other than this breast cancer, except for non-melanoma skin cancers.
- Completed all therapy (including endocrine therapy) \<5 years ago for any previous invasive solid organ malignancy (with exception of non-melanoma skin cancers) including prior breast cancer. Individuals with a prior history of noninvasive (in situ) carcinomas may participate if they have received definitive treatment.
- Completed all therapy for any previous hematologic malignancy \< 5 years ago.
- Multicentric or contralateral invasive breast cancers.
- Known pregnancy at time of enrollment.
- Prior solid organ transplant.
- Prior allogeneic hematopoietic stem cell transplant.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (58 Sites)
- Katmai Oncology Group - Anchorage — Anchorage, Alaska
- Stanford Cancer Institute — Palo Alto, California
- Harbor-UCLA Medical Center - Hematology / Oncology — Torrance, California
- Kaiser Permanente Medical Center — Vallejo, California
- UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center — Aurora, Colorado
- AdventHealth East Altamonte Oncology and Hematology — Altamonte Springs, Florida
- Mount Sinai Medical - Comprehensive Cancer Center — Miami Beach, Florida
- Baptist Cancer Care - Plantation — Plantation, Florida
- St. Joseph's Women's Hospital — Tampa, Florida
- Rush Cancer Center — Chicago, Illinois
- Deaconess Chancellor Center for Oncology — Newburgh, Indiana
- University of Kansas Cancer Center — Westwood, Kansas
- St. Elizabeth Edgewood Hospital — Edgewood, Kentucky
- Norton Cancer Institute - Downtown — Louisville, Kentucky
- Baptist Health Louisville — Louisville, Kentucky
- Weinberg Center at Mercy — Baltimore, Maryland
- Greater Baltimore Medical Center — Baltimore, Maryland
- Sinai Hospital of Baltimore — Baltimore, Maryland
- MedStar Georgetown Cancer Institute — Baltimore, Maryland
- The Center for Cancer and Blood Disorders - Bethesda — Bethesda, Maryland
- James M Stockman Cancer Institute — Frederick, Maryland
- Tate Cancer Center at UM Baltimore Washington — Glen Burnie, Maryland
- Meritus Center for Clinical Research — Hagerstown, Maryland
- Holy Cross Hospital - Silver Spring — Silver Spring, Maryland
- University of Maryland St. Joseph Medical Center — Towson, Maryland
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.