๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-01-16

EXActDNA-003 / NSABP B-64: Study of Molecular Residual Disease Detection in Breast Cancer (MRD) (NCT06401421)

EXActDNA-003 / NSABP B-64: Breast Cancer Clinical Validation Study to Predict Recurrence of High-Risk Early Breast Cancer Treated With Neoadjuvant Therapy Using a Bespoke Circulating Tumor DNA Assay to Detect Molecular Residual Disease

๐ŸŸข Recruiting Interventional Protocol ๐Ÿ“Š Observational Clinical Research Sponsor: Exact Sciences Corporation

๐Ÿฉบ 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: Review the eligibility criteria below.

Location: Katmai Oncology Group - Anchorage โ€” Anchorage, Alaska

Age range: 18 Years

๐Ÿงช Interventions in This Study

  • ctDNA MRD test (DIAGNOSTIC_TEST)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (58 Sites)

Showing the first 25 of 58 sites.

  • Katmai Oncology Group - Anchorage โ€” Anchorage, Alaska
  • Stanford Cancer Institute โ€” Palo Alto, California
  • Harbor-UCLA Medical Center - Hematology / Oncology โ€” Torrance, California
  • Kaiser Permanente Medical Center โ€” Vallejo, California
  • UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center โ€” Aurora, Colorado
  • AdventHealth East Altamonte Oncology and Hematology โ€” Altamonte Springs, Florida
  • Mount Sinai Medical - Comprehensive Cancer Center โ€” Miami Beach, Florida
  • Baptist Cancer Care - Plantation โ€” Plantation, Florida
  • St. Joseph's Women's Hospital โ€” Tampa, Florida
  • Rush Cancer Center โ€” Chicago, Illinois
  • Deaconess Chancellor Center for Oncology โ€” Newburgh, Indiana
  • University of Kansas Cancer Center โ€” Westwood, Kansas
  • St. Elizabeth Edgewood Hospital โ€” Edgewood, Kentucky
  • Norton Cancer Institute - Downtown โ€” Louisville, Kentucky
  • Baptist Health Louisville โ€” Louisville, Kentucky
  • Weinberg Center at Mercy โ€” Baltimore, Maryland
  • Greater Baltimore Medical Center โ€” Baltimore, Maryland
  • Sinai Hospital of Baltimore โ€” Baltimore, Maryland
  • MedStar Georgetown Cancer Institute โ€” Baltimore, Maryland
  • The Center for Cancer and Blood Disorders - Bethesda โ€” Bethesda, Maryland
  • James M Stockman Cancer Institute โ€” Frederick, Maryland
  • Tate Cancer Center at UM Baltimore Washington โ€” Glen Burnie, Maryland
  • Meritus Center for Clinical Research โ€” Hagerstown, Maryland
  • Holy Cross Hospital - Silver Spring โ€” Silver Spring, Maryland
  • University of Maryland St. Joseph Medical Center โ€” Towson, Maryland

๐Ÿ“ž Contact the Study Coordinator

Phone: (800) 270-3165

Email: industry.trials@nsabp.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ 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 ยง 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.

Explore by condition: All Breast Cancer clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—