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Recruiting No phase listed Observational

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

ClinicalTrials.gov ID: NCT06401421

Public ClinicalTrials.gov record NCT06401421. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 1:13 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06401421
Recruitment status
Recruiting
Study type
Observational
Phase
Not listed
Lead sponsor
Exact Sciences Corporation
Industry
Enrollment
1,800 participants

Conditions and interventions

Conditions

Interventions

Diagnostic Test

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 6, 2024
Primary completion
Mar 31, 2030
Completion
Mar 31, 2030
Last update posted
Jan 19, 2026

2024 – 2030

United States locations

U.S. sites
53
U.S. states
25
U.S. cities
48
Facility City State ZIP Site status
Katmai Oncology Group - Anchorage Anchorage Alaska 99508 Recruiting
Stanford Cancer Institute Palo Alto California 94304 Recruiting
Harbor-UCLA Medical Center - Hematology / Oncology Torrance California 90502 Recruiting
Kaiser Permanente Medical Center Vallejo California 94589 Recruiting
UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center Aurora Colorado 80045 Recruiting
AdventHealth East Altamonte Oncology and Hematology Altamonte Springs Florida 32701 Recruiting
Mount Sinai Medical - Comprehensive Cancer Center Miami Beach Florida 33140 Recruiting
Baptist Cancer Care - Plantation Plantation Florida 33324 Recruiting
St. Joseph's Women's Hospital Tampa Florida 33607 Recruiting
Rush Cancer Center Chicago Illinois 60607 Recruiting
Deaconess Chancellor Center for Oncology Newburgh Indiana 47630 Recruiting
University of Kansas Cancer Center Westwood Kansas 66205 Recruiting
St. Elizabeth Edgewood Hospital Edgewood Kentucky 41017 Recruiting
Norton Cancer Institute - Downtown Louisville Kentucky 40202 Recruiting
Baptist Health Louisville Louisville Kentucky 40207 Recruiting
Weinberg Center at Mercy Baltimore Maryland 21202 Recruiting
Greater Baltimore Medical Center Baltimore Maryland 21204 Recruiting
Sinai Hospital of Baltimore Baltimore Maryland 21215 Recruiting
MedStar Georgetown Cancer Institute Baltimore Maryland 21237 Recruiting
The Center for Cancer and Blood Disorders - Bethesda Bethesda Maryland 20818 Recruiting
James M Stockman Cancer Institute Frederick Maryland 21702 Recruiting
Tate Cancer Center at UM Baltimore Washington Glen Burnie Maryland 21061 Recruiting
Meritus Center for Clinical Research Hagerstown Maryland 21742 Recruiting
Holy Cross Hospital - Silver Spring Silver Spring Maryland 20910 Recruiting
University of Maryland St. Joseph Medical Center Towson Maryland 21204 Recruiting
Lahey Hospital & Medical Center Burlington Massachusetts 01805 Recruiting
Metro Minnesota Community Oncology Consortium (MMCORC) Saint Louis Park Minnesota 55426 Recruiting
Saint Luke's Hospital of Kansas City Kansas City Missouri 64111 Recruiting
John Theurer Cancer Center Hackensack New Jersey 07601 Recruiting
Rutgers Cancer Institute of New Jersey New Brunswick New Jersey 08901 Recruiting
Stony Brook Medicine Stony Brook New York 11794 Recruiting
Atrium Health Levine Cancer Institute Charlotte North Carolina 28204 Recruiting
Novant Health Cancer Institute - Elizabeth Charlotte North Carolina 28204 Recruiting
FirstHealth Outpatient Cancer Center Pinehurst North Carolina 28374 Recruiting
UNC Cancer Care at Nash Rocky Mount North Carolina 27804 Recruiting
Atrium Health Wake Forest Baptist Medical Center Winston-Salem North Carolina 27157 Recruiting
Aultman Timken Family Cancer Center Canton Ohio 44710 Recruiting
Cleveland Clinic Main Campus Cleveland Ohio 44195 Recruiting
Penn State Health Medical Group - Andrews Patel Harrisburg Pennsylvania 17111 Recruiting
Penn State Cancer Institute Hershey Pennsylvania 17033 Recruiting
UPMC Magee - Womens Hospital Pittsburgh Pennsylvania 15213 Recruiting
Guthrie Sayre Sayre Pennsylvania 18840 Recruiting
Women & Infants Hospital Providence Rhode Island 02905 Recruiting
Spartanburg Medical Center Spartanburg South Carolina 29303 Recruiting
Avera Cancer Institute Sioux Falls South Dakota 57105 Recruiting
Ballad Health Cancer Center Kingsport Tennessee 37660 Recruiting
The University of Texas MD Anderson Cancer Center Houston Texas 77030 Recruiting
Joe Arrington Cancer Research & Treatment Center Lubbock Texas 79410 Recruiting
Alan B. Pearson Regional Cancer Center Lynchburg Virginia 24501 Recruiting
Bon Secours Cancer Institute at St. Francis Midlothian Virginia 23114 Recruiting
VCU Massey Comprehensive Cancer Center Richmond Virginia 23298 Recruiting
WVU Cancer Institute Morgantown West Virginia 26505 Recruiting
Aurora Cancer Care - Wauwatosa Wauwatosa Wisconsin 53226 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06401421, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 19, 2026 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06401421 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →