Loading clinical trials...

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

RECRUITING

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

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

NCT06401421•Exact Sciences Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The participant or a legally authorized representative must provide study-specific informed consent prior to study entry.
•2. The participant must be ≥ 18 years of age.
•3. ECOG performance status 0 or 1.
•4. Histologically confirmed invasive carcinoma of the breast.
•5. Planned neoadjuvant therapy which includes cytotoxic chemotherapy.
•6. Tumor size ≥ 2.1 cm in greatest diameter.
•7. Unifocal or multifocal cancer documented to be the same histologic clinical subtype.
•8. Clinically node positive or if node negative, any one of the following:
•1. TNBC or HER2+ subtype
•2. HR+/HER2-negative with at least one of the following:
+3 more criteria

Exclusion Criteria

•1. Definitive clinical or radiologic evidence of metastatic disease.
•2. Initiated neoadjuvant therapy for current breast cancer diagnosis.
•3. Synchronous diagnosis of another invasive cancer, other than this breast cancer, except for non-melanoma skin cancers.
•4. 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.
•5. Completed all therapy for any previous hematologic malignancy \< 5 years ago.
•6. Multicentric or contralateral invasive breast cancers.
•7. Known pregnancy at time of enrollment.
•8. Prior solid organ transplant.
•9. Prior allogeneic hematopoietic stem cell transplant.

Locations (58)

Katmai Oncology Group - Anchorage

Anchorage, Alaska, United States

Stanford Cancer Institute

Palo Alto, California, United States

Harbor-UCLA Medical Center - Hematology / Oncology

Torrance, California, United States

Kaiser Permanente Medical Center

Vallejo, California, United States

UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center

Aurora, Colorado, United States

AdventHealth East Altamonte Oncology and Hematology

Altamonte Springs, Florida, United States

Mount Sinai Medical - Comprehensive Cancer Center

Miami Beach, Florida, United States

Baptist Cancer Care - Plantation

Plantation, Florida, United States

St. Joseph's Women's Hospital

Tampa, Florida, United States

Rush Cancer Center

Chicago, Illinois, United States

Key Dates

Start Date

June 7, 2024

Primary Completion Date

April 1, 2030

Completion Date

April 1, 2030

Last Updated

January 20, 2026

Enrollment

1,800

ESTIMATED participants

Conditions

Breast Cancer

Interventions

ctDNA MRD test

DIAGNOSTIC_TEST

Contacts

NSABP Department of Site and Study Management Department of Site and Study Management

CONTACT

1-800-270-3165 industry.trials@nsabp.org

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

NCT04704661

Advanced Breast CarcinomaAdvanced Colon Carcinoma+38 more

View study

RECRUITINGPHASE1

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

NCT05673200

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer