Recruiting

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

Sponsor:

Exact Sciences Corporation

Code:

NCT06401421

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ctDNA MRD test

Study Details

Brief 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

Breast Cancer

Study ID

NCT06401421

Start date

Jun 7, 2024

Status verified date

Jan, 2026

Completion date

Apr, 2030

Anticipated

Primary completion date

Apr, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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:

i. High tumor grade (G3) ii. Ki67 index of 20% or higher iii. High genomic risk (Oncotype DX® (ODX) Breast Recurrence Score of > 25, MammaPrint® High, etc.)
9. Willing and able to comply with the study requirements, which includes the collection of a total of 34 cc (2.5 Tablespoons) of blood for each research blood draw.
10. Available residual tissue from diagnostic biopsy from the breast or an involved ipsilateral lymph node for submission to create a bespoke ctDNA assay.

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.

Study Design

Enrollment

1800 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants with High Risk Early Breast Cancer

Interventions

ctDNA MRD test

Blood and tissue samples will be collected for the ctDNA MRD test

Primary outcome measure

Core biopsy tissue evaluability rate [ Time Frame: 3 years ]
Distant Recurrence Free Interval (dRFI) [ Time Frame: 6 years ]

Central Contacts and Locations

Central contacts

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

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

Locations

Katmai Oncology Group - Anchorage

Recruiting

Anchorage, Alaska, United States, 99508

Stanford Cancer Institute

Recruiting

Palo Alto, California, United States, 94304

Harbor-UCLA Medical Center - Hematology / Oncology

Recruiting

Torrance, California, United States, 90502

Kaiser Permanente Medical Center

Recruiting

Vallejo, California, United States, 94589

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

Recruiting

Aurora, Colorado, United States, 80045

AdventHealth East Altamonte Oncology and Hematology

Recruiting

Altamonte Springs, Florida, United States, 32701

Mount Sinai Medical - Comprehensive Cancer Center

Recruiting

Miami Beach, Florida, United States, 33140

Baptist Cancer Care - Plantation

Recruiting

Plantation, Florida, United States, 33324

St. Joseph's Women's Hospital

Recruiting

Tampa, Florida, United States, 33607

Rush Cancer Center

Recruiting

Chicago, Illinois, United States, 60607

Deaconess Chancellor Center for Oncology

Recruiting

Newburgh, Indiana, United States, 47630

University of Kansas Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

St. Elizabeth Edgewood Hospital

Recruiting

Edgewood, Kentucky, United States, 41017

Norton Cancer Institute - Downtown

Recruiting

Louisville, Kentucky, United States, 40202

Baptist Health Louisville

Recruiting

Louisville, Kentucky, United States, 40207

Weinberg Center at Mercy

Recruiting

Baltimore, Maryland, United States, 21202

Greater Baltimore Medical Center

Recruiting

Baltimore, Maryland, United States, 21204

Sinai Hospital of Baltimore

Recruiting

Baltimore, Maryland, United States, 21215

MedStar Georgetown Cancer Institute

Recruiting

Baltimore, Maryland, United States, 21237

The Center for Cancer and Blood Disorders - Bethesda

Recruiting

Bethesda, Maryland, United States, 20818

James M Stockman Cancer Institute

Recruiting

Frederick, Maryland, United States, 21702

Tate Cancer Center at UM Baltimore Washington

Recruiting

Glen Burnie, Maryland, United States, 21061

Meritus Center for Clinical Research

Recruiting

Hagerstown, Maryland, United States, 21742

Holy Cross Hospital - Silver Spring

Recruiting

Silver Spring, Maryland, United States, 20910

University of Maryland St. Joseph Medical Center

Recruiting

Towson, Maryland, United States, 21204

Lahey Hospital & Medical Center

Recruiting

Burlington, Massachusetts, United States, 01805

Metro Minnesota Community Oncology Consortium (MMCORC)

Recruiting

Saint Louis Park, Minnesota, United States, 55426

Saint Luke's Hospital of Kansas City

Recruiting

Kansas City, Missouri, United States, 64111

John Theurer Cancer Center

Recruiting

Hackensack, New Jersey, United States, 07601

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08901

Stony Brook Medicine

Recruiting

Stony Brook, New York, United States, 11794

Atrium Health Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Novant Health Cancer Institute - Elizabeth

Recruiting

Charlotte, North Carolina, United States, 28204

FirstHealth Outpatient Cancer Center

Recruiting

Pinehurst, North Carolina, United States, 28374

UNC Cancer Care at Nash

Recruiting

Rocky Mount, North Carolina, United States, 27804

Atrium Health Wake Forest Baptist Medical Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Aultman Timken Family Cancer Center

Recruiting

Canton, Ohio, United States, 44710

Cleveland Clinic Main Campus

Recruiting

Cleveland, Ohio, United States, 44195

Penn State Health Medical Group - Andrews Patel

Recruiting

Harrisburg, Pennsylvania, United States, 17111

Penn State Cancer Institute

Recruiting

Hershey, Pennsylvania, United States, 17033

UPMC Magee - Womens Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Guthrie Sayre

Recruiting

Sayre, Pennsylvania, United States, 18840

Women & Infants Hospital

Recruiting

Providence, Rhode Island, United States, 02905

Spartanburg Medical Center

Recruiting

Spartanburg, South Carolina, United States, 29303

Avera Cancer Institute

Recruiting

Sioux Falls, South Dakota, United States, 57105

Ballad Health Cancer Center

Recruiting

Kingsport, Tennessee, United States, 37660

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Joe Arrington Cancer Research & Treatment Center

Recruiting

Lubbock, Texas, United States, 79410

Alan B. Pearson Regional Cancer Center

Recruiting

Lynchburg, Virginia, United States, 24501

Bon Secours Cancer Institute at St. Francis

Recruiting

Midlothian, Virginia, United States, 23114

VCU Massey Comprehensive Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

WVU Cancer Institute

Recruiting

Morgantown, West Virginia, United States, 26505

Aurora Cancer Care - Wauwatosa

Recruiting

Wauwatosa, Wisconsin, United States, 53226

Maisonneuve-Rosemont Hospital (HMR)

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Centre Hospitalier de l'Université de Montréal (CHUM)

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T1E2

McGill University Health - Glen Site

Recruiting

Montreal, Quebec, Canada

Hôpital du Saint-Sacrement

Recruiting

Québec, Quebec, Canada, G1S 4L8

More Information

Sponsor

Exact Sciences Corporation

Last update posted

Jan 20, 2026

Last verified

Jan, 2026

Keywords

Breast Cancer
ctDNA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Exact Sciences Corporation on 2026-01-20.