AzTrials
AzTrials

Breast CancerNCT06401421

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

An observational study of Breast Cancer, run by Exact Sciences Corporation at 61 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
ctDNA MRD test
How many people
1,800 participants
Where
61 sitesin 2 countries
Study dates
7 Jun 2024to Apr 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • The participant or a legally authorized representative must provide study-specific informed consent prior to study entry.
  • The participant must be ≥ 18 years of age.
  • ECOG performance status 0 or 1.
  • Histologically confirmed invasive carcinoma of the breast.
  • Planned neoadjuvant therapy which includes cytotoxic chemotherapy.
  • Tumor size ≥ 2.1 cm in greatest diameter.
Show all 13Show fewer
  • Unifocal or multifocal cancer documented to be the same histologic clinical subtype.
  • Clinically node positive or if node negative, any one of the following:
  • TNBC or HER2+ subtype
  • HR+/HER2-negative with at least one of the following:
  • 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.)
  • 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.
  • Available residual tissue from diagnostic biopsy from the breast or an involved ipsilateral lymph node for submission to create a bespoke ctDNA assay.

Who cannot join

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

Trial locations and contacts

61 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

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

1-800-270-3165

industry.trials@nsabp.org

61 sites in 2 countries

United States56 sites, 56 recruiting

  • AdventHealth East Altamonte Oncology and Hematology

    Altamonte, Florida, 32701

    Wassim Mchayleh

    Recruiting

  • Katmai Oncology Group - Anchorage

    Anchorage, Alaska, 99508

    Theodore Kim

    Recruiting

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

    Aurora, Colorado, 80045

    Marie Wood

    Recruiting

  • Weinberg Center at Mercy

    Baltimore, Maryland, 21202

    David Riseberg

    Recruiting

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

    Robert Donegan

    Recruiting

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

    Qiwei Gai

    Recruiting

  • MedStar Georgetown Cancer Institute

    Baltimore, Maryland, 21237

    Shweta Kurian

    Recruiting

  • The Center for Cancer and Blood Disorders - Bethesda

    Bethesda, Maryland, 20818

    Victor Priego

    Recruiting

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts, 01805

    Maria Galkin

    Recruiting

  • Aultman Timken Family Cancer Center

    Canton, Ohio, 44710

    Sunitha Vemulapalli

    Recruiting

  • Atrium Health Levine Cancer Institute

    Charlotte, North Carolina, 28204

    Arielle Heeke

    Recruiting

  • Novant Health Cancer Institute - Elizabeth

    Charlotte, North Carolina, 28204

    Kimberly Strickland

    Recruiting

  • Rush Cancer Center

    Chicago, Illinois, 60607

    Ruta Rao

    Recruiting

  • Cleveland Clinic Main Campus

    Cleveland, Ohio, 44195

    Erin Roesch

    Recruiting

  • St. Elizabeth Edgewood Hospital

    Edgewood, Kentucky, 41017

    Daniel Flora

    Recruiting

  • James M Stockman Cancer Institute

    Frederick, Maryland, 21702

    Natalia Marina

    Recruiting

  • Tate Cancer Center at UM Baltimore Washington

    Glen Burnie, Maryland, 21061

    Aaron Iddings

    Recruiting

  • John Theurer Cancer Center

    Hackensack, New Jersey, 07601

    Deena Graham

    Recruiting

  • Meritus Center for Clinical Research

    Hagerstown, Maryland, 21742

    Victoria Giffi

    Recruiting

  • Penn State Health Medical Group - Andrews Patel

    Harrisburg, Pennsylvania, 17111

    Kumudini Rao

    Recruiting

  • Penn State Cancer Institute

    Hershey, Pennsylvania, 17033

    Cristina Truica

    Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Vincente Valero

    Recruiting

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

    Whitney Hensing

    Recruiting

  • Ballad Health Cancer Center

    Kingsport, Tennessee, 37660

    Asheesh Shipstone

    Recruiting

  • Norton Cancer Institute - Downtown

    Louisville, Kentucky, 40202

    John Hamm

    Recruiting

  • Baptist Health Louisville

    Louisville, Kentucky, 40207

    Mounika Mandadi

    Recruiting

  • Joe Arrington Cancer Research & Treatment Center

    Lubbock, Texas, 79410

    Ibrahim Shalaby

    Recruiting

  • Alan B. Pearson Regional Cancer Center

    Lynchburg, Virginia, 24501

    Michael O'Neill

    Recruiting

  • Mount Sinai Medical - Comprehensive Cancer Center

    Miami Beach, Florida, 33140

    Oleg Gligich

    Recruiting

  • Bon Secours Cancer Institute at St. Francis

    Midlothian, Virginia, 23114

    William Irvin

    Recruiting

  • Froedtert Hospital - MCW Clinical Trials Office

    Milwaukee, Wisconsin, 53226

    Lubna Chaudhary

    Recruiting

  • WVU Cancer Institute

    Morgantown, West Virginia, 26505

    Bei Jiang

    Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

    Mridula George

    Recruiting

  • Breast Center at Weill Cornell Medicine

    New York, New York, 10065

    Eleni Andreopoulou

    Recruiting

  • Deaconess Chancellor Center for Oncology

    Newburgh, Indiana, 47630

    Samer Schuman

    Recruiting

  • Orlando Health Cancer Institute - Downtown Orlando

    Orlando, Florida, 32806

    Susan Constantino

    Recruiting

  • Stanford Cancer Institute

    Palo Alto, California, 94304

    Irene Wapnir

    Recruiting

  • FirstHealth Outpatient Cancer Center

    Pinehurst, North Carolina, 28374

    Charles Kuzma

    Recruiting

  • UPMC Magee - Womens Hospital

    Pittsburgh, Pennsylvania, 15213

    Julia Foldi

    Recruiting

  • Baptist Cancer Care - Plantation

    Plantation, Florida, 33324

    Lauren Carcas

    Recruiting

  • Women & Infants Hospital

    Providence, Rhode Island, 02905

    William Sikov

    Recruiting

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298

    Hetal Vachhani

    Recruiting

  • UNC Cancer Care at Nash

    Rocky Mount, North Carolina, 27804

    Elie Choufani

    Recruiting

  • Metro Minnesota Community Oncology Consortium (MMCORC)

    Saint Louis Park, Minnesota, 55426

    Yan Ji

    Recruiting

  • Guthrie Sayre

    Sayre, Pennsylvania, 18840

    Mohammed Ziauddin

    Recruiting

  • Holy Cross Hospital - Silver Spring

    Silver Spring, Maryland, 20910

    Dawn Leonard

    Recruiting

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

    Jason Jones

    Recruiting

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

    Isaac Alwine

    Recruiting

  • Stony Brook Medicine

    Stony Brook, New York, 11794

    Alison Stopeck

    Recruiting

  • St. Joseph's Women's Hospital

    Tampa, Florida, 33607

    Robert Gabordi

    Recruiting

  • Harbor-UCLA Medical Center - Hematology / Oncology

    Torrance, California, 90502

    Jennifer Lee

    Recruiting

  • University of Maryland St. Joseph Medical Center

    Towson, Maryland, 21204

    Ethan Rogers

    Recruiting

  • Kaiser Permanente Medical Center

    Vallejo, California, 94589

    Samantha Seaward

    Recruiting

  • Aurora Cancer Care - Wauwatosa

    Wauwatosa, Wisconsin, 53226

    Peter Polewski

    Recruiting

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

    Julia White

    Recruiting

  • Atrium Health Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

    Katherine Ansley

    Recruiting

Other trials in United States

Canada5 sites, 5 recruiting

  • Maisonneuve-Rosemont Hospital (HMR)

    Montreal, Quebec, H1T 2M4

    Lucas Sideris

    Recruiting

  • Centre Hospitalier de l'Université de Montréal (CHUM)

    Montreal, Quebec, H2X 3E4

    Erica Patocskai

    Recruiting

  • Jewish General Hospital

    Montreal, Quebec, H3T1E2

    Mark Basik

    Recruiting

  • McGill University Health - Glen Site

    Montreal, Quebec

    Nathaniel Bouganim

    Recruiting

  • Hôpital du Saint-Sacrement

    Québec, Quebec, G1S 4L8

    Dominique Boudreau

    Recruiting

Other trials in Canada

About this study

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

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
Being tested
ctDNA MRD test
Keywords
Breast Cancer, ctDNA
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ctDNA MRD testDiagnostic test

    Also called Oncodetect™

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

Study groups in NCT06401421
Study groupRoleWhat they receive
Participants with High Risk Early Breast CancerParticipants with High Risk Early Breast Cancer
Receives: Diagnostic Test: ctDNA MRD test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Core biopsy tissue evaluability rate

    Measured: 3 years

  2. Distant Recurrence Free Interval (dRFI)

    Measured: 6 years

Secondary outcomes (9)

  1. Prevalence of tumor mutations and germline variants

    Measured: 6 years

  2. Sensitivity/Specificity

    Measured: 6 years

  3. Prevalence of test positivity

    Measured: 6 years

  4. Pathologic complete response (pCR) status

    Measured: 6 years

  5. Recurrence-free interval (RFI)

    Measured: 6 years

  6. Invasive breast cancer-free survival (IBCFS)

    Measured: 6 years

  7. Event-free survival (EFS)

    Measured: 6 years

  8. Overall survival (OS)

    Measured: 6 years

  9. Lead Time

    Measured: 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2024
  2. Study start7 Jun 2024
  3. Primary completionApr 2030 (estimated)
  4. Study completionApr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06401421
Sponsor's protocol ID
2023-05
Status last verified
Jan 2026
First submitted
2 May 2024
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by Exact Sciences Corporation at 61 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact NSABP Department of Site and Study Management Department of Site and Study Management (1-800-270-3165, industry.trials@nsabp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Core biopsy tissue evaluability rate (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06401421.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in