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

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: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Diagnostic test: ctDNA MRD test

• Study Type: Observational
• Enrollment (Estimated): 1800

Contacts and Locations

• Study Contact: 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'Universite de Montreal (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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Time Frame
Core biopsy tissue evaluability rate	3 years
Distant Recurrence Free Interval (dRFI)	6 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival (OS)	6 years
Prevalence of tumor mutations and germline variants	6 years
Sensitivity/Specificity	6 years
Prevalence of test positivity	6 years
Pathologic complete response (pCR) status	6 years
Recurrence-free interval (RFI)	6 years
Invasive breast cancer-free survival (IBCFS)	6 years
Event-free survival (EFS)	6 years
Lead Time	6 years

Collaborators and Investigators

• Sponsor: Exact Sciences Corporation
• Collaborators: NSABP Foundation Inc

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2024
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030

Study Registration Dates

• First Submitted: May 2, 2024
• First Submitted That Met QC Criteria: May 2, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Breast Cancer; ctDNA
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID 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