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

January 16, 2026 updated by: Exact Sciences Corporation

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: NSABP Department of Site and Study Management Department of Site and Study Management
  • Phone Number: 1-800-270-3165
  • Email: industry.trials@nsabp.org

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
        • Recruiting
        • Centre Hospitalier de l'Université de Montréal (CHUM)
        • Contact:
          • Erica Patocskai
      • Montreal, Quebec, Canada, H3T1E2
        • Recruiting
        • Jewish General Hospital
        • Contact:
          • Mark Basik
      • Montreal, Quebec, Canada, H1T 2M4
        • Recruiting
        • Maisonneuve-Rosemont Hospital (HMR)
        • Contact:
          • Lucas Sideris
      • Montreal, Quebec, Canada
        • Recruiting
        • McGill University Health - Glen Site
        • Contact:
          • Nathaniel Bouganim
      • Québec, Quebec, Canada, G1S 4L8
        • Recruiting
        • Hôpital du Saint-Sacrement
        • Contact:
          • Dominique Boudreau
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Recruiting
        • Katmai Oncology Group - Anchorage
        • Contact:
          • Theodore Kim
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford Cancer Institute
        • Contact:
          • Irene Wapnir
      • Torrance, California, United States, 90502
        • Recruiting
        • Harbor-UCLA Medical Center - Hematology / Oncology
        • Contact:
          • Jennifer Lee
      • Vallejo, California, United States, 94589
        • Recruiting
        • Kaiser Permanente Medical Center
        • Contact:
          • Samantha Seaward
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center
        • Contact:
          • Marie Wood
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Recruiting
        • AdventHealth East Altamonte Oncology and Hematology
        • Contact:
          • Wassim Mchayleh
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Medical - Comprehensive Cancer Center
        • Contact:
          • Oleg Gligich
      • Plantation, Florida, United States, 33324
        • Recruiting
        • Baptist Cancer Care - Plantation
        • Contact:
          • Lauren Carcas
      • Tampa, Florida, United States, 33607
        • Recruiting
        • St. Joseph's Women's Hospital
        • Contact:
          • Robert Gabordi
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Recruiting
        • Rush Cancer Center
        • Contact:
          • Ruta Rao
    • Indiana
      • Newburgh, Indiana, United States, 47630
        • Recruiting
        • Deaconess Chancellor Center for Oncology
        • Contact:
          • Samer Schuman
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Cancer Center
        • Contact:
          • Julia White
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Recruiting
        • St. Elizabeth Edgewood Hospital
        • Contact:
          • Daniel Flora
      • Louisville, Kentucky, United States, 40207
        • Recruiting
        • Baptist Health Louisville
        • Contact:
          • Mounika Mandadi
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Norton Cancer Institute - Downtown
        • Contact:
          • John Hamm
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Recruiting
        • Greater Baltimore Medical Center
        • Contact:
          • Robert Donegan
      • Baltimore, Maryland, United States, 21215
        • Recruiting
        • Sinai Hospital of Baltimore
        • Contact:
          • Qiwei Gai
      • Baltimore, Maryland, United States, 21237
        • Recruiting
        • Medstar Georgetown Cancer Institute
        • Contact:
          • Shweta Kurian
      • Baltimore, Maryland, United States, 21202
        • Recruiting
        • Weinberg Center at Mercy
        • Contact:
          • David Riseberg
      • Bethesda, Maryland, United States, 20818
        • Recruiting
        • The Center for Cancer and Blood Disorders - Bethesda
        • Contact:
          • Victor Priego
      • Frederick, Maryland, United States, 21702
        • Recruiting
        • James M Stockman Cancer Institute
        • Contact:
          • Natalia Marina
      • Glen Burnie, Maryland, United States, 21061
        • Recruiting
        • Tate Cancer Center at UM Baltimore Washington
        • Contact:
          • Aaron Iddings
      • Hagerstown, Maryland, United States, 21742
        • Recruiting
        • Meritus Center for Clinical Research
        • Contact:
          • Victoria Giffi
      • Silver Spring, Maryland, United States, 20910
        • Recruiting
        • Holy Cross Hospital - Silver Spring
        • Contact:
          • Cheryl Aylesworth
      • Towson, Maryland, United States, 21204
        • Recruiting
        • University of Maryland St. Joseph Medical Center
        • Contact:
          • Ethan Rogers
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Recruiting
        • Lahey Hospital & Medical Center
        • Contact:
          • Ragisha Gopalakrishnan
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55426
        • Recruiting
        • Metro Minnesota Community Oncology Consortium (MMCORC)
        • Contact:
          • Yan Ji
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Saint Luke's Hospital of Kansas City
        • Contact:
          • Whitney Hensing
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • John Theurer Cancer Center
        • Contact:
          • Deena Graham
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Contact:
          • Mridula George
    • New York
      • Stony Brook, New York, United States, 11794
        • Recruiting
        • Stony Brook Medicine
        • Contact:
          • Alison Stopeck
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Atrium Health Levine Cancer Institute
        • Contact:
          • Arielle Heeke
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Novant Health Cancer Institute - Elizabeth
        • Contact:
          • Kimberly Strickland
      • Pinehurst, North Carolina, United States, 28374
        • Recruiting
        • FirstHealth Outpatient Cancer Center
        • Contact:
          • Charles Kuzma
      • Rocky Mount, North Carolina, United States, 27804
        • Recruiting
        • UNC Cancer Care at Nash
        • Contact:
          • Elie Choufani
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Atrium Health Wake Forest Baptist Medical Center
        • Contact:
          • Katherine Ansley
    • Ohio
      • Canton, Ohio, United States, 44710
        • Recruiting
        • Aultman Timken Family Cancer Center
        • Contact:
          • Sunitha Vemulapalli
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Main Campus
        • Contact:
          • Shimoli Barot
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17111
        • Recruiting
        • Penn State Health Medical Group - Andrews Patel
        • Contact:
          • Kumudini Rao
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State Cancer Institute
        • Contact:
          • Cristina Truica
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • UPMC Magee - Womens Hospital
        • Contact:
          • Julia Foldi
      • Sayre, Pennsylvania, United States, 18840
        • Recruiting
        • Guthrie Sayre
        • Contact:
          • Mohammed Ziauddin
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Recruiting
        • Women & Infants Hospital
        • Contact:
          • William Sikov
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • Spartanburg Medical Center
        • Contact:
          • Isaac Alwine
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Avera Cancer Institute
        • Contact:
          • Jason Jones
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Recruiting
        • Ballad Health Cancer Center
        • Contact:
          • Asheesh Shipstone
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas MD Anderson Cancer Center
        • Contact:
          • Vincente Valero
      • Lubbock, Texas, United States, 79410
        • Recruiting
        • Joe Arrington Cancer Research & Treatment Center
        • Contact:
          • Ibrahim Shalaby
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • Recruiting
        • Alan B. Pearson Regional Cancer Center
        • Contact:
          • Michael O'Neill
      • Midlothian, Virginia, United States, 23114
        • Recruiting
        • Bon Secours Cancer Institute at St. Francis
        • Contact:
          • William Irvin
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • VCU Massey Comprehensive Cancer Center
        • Contact:
          • Elizabeth Barrows
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Recruiting
        • WVU Cancer Institute
        • Contact:
          • Sobha Kurian
    • Wisconsin
      • Wauwatosa, Wisconsin, United States, 53226
        • Recruiting
        • Aurora Cancer Care - Wauwatosa
        • Contact:
          • Peter Polewski

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients over the age of 18 who will undergo neoadjuvant treatment for high-risk, early breast cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Participants with High Risk Early Breast Cancer
Diagnostic test: ctDNA MRD test
Blood and tissue samples will be collected for the ctDNA MRD test
Other Names:
  • Oncodetect™

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Core biopsy tissue evaluability rate
Time Frame: 3 years
3 years
Distant Recurrence Free Interval (dRFI)
Time Frame: 6 years
6 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: 6 years
6 years
Prevalence of tumor mutations and germline variants
Time Frame: 6 years
6 years
Sensitivity/Specificity
Time Frame: 6 years
6 years
Prevalence of test positivity
Time Frame: 6 years
6 years
Pathologic complete response (pCR) status
Time Frame: 6 years
6 years
Recurrence-free interval (RFI)
Time Frame: 6 years
6 years
Invasive breast cancer-free survival (IBCFS)
Time Frame: 6 years
6 years
Event-free survival (EFS)
Time Frame: 6 years
6 years
Lead Time
Time Frame: 6 years
6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Exact Sciences Corporation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
NSABP Foundation Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 7, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include test, tables, figured, and appendices. The study protocol, statistical analysis plan (when applicable), informed consent form (when applicable). May not be reproduced nor disseminated outside of Exact Sciences without permission and the clinical study report (when applicable) will also be shared

IPD Sharing Time Frame

Data will be available from 2 years and ending 4 years after publication

IPD Sharing Access Criteria

Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary Institutional Review Board (IRB)/Institutional Ethics Committee (IEC) approvals or waivers as applicable to conduct research.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings