RecruitingObservational

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

NCT ID: NCT06401421Sponsor: Exact Sciences CorporationLast updated: 2026-01-20

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.

Arms & interventions

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

Outcome measures

Primary

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

Secondary

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

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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 locations (53)

Katmai Oncology Group - Anchorage

Anchorage, Alaska, 99508

Recruiting

Theodore Kim · Contact

Stanford Cancer Institute

Palo Alto, California, 94304

Recruiting

Irene Wapnir · Contact

Harbor-UCLA Medical Center - Hematology / Oncology

Torrance, California, 90502

Recruiting

Jennifer Lee · Contact

Kaiser Permanente Medical Center

Vallejo, California, 94589

Recruiting

Samantha Seaward · Contact

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

Aurora, Colorado, 80045

Recruiting

Marie Wood · Contact

AdventHealth East Altamonte Oncology and Hematology

Altamonte Springs, Florida, 32701

Recruiting

Wassim Mchayleh · Contact

Mount Sinai Medical - Comprehensive Cancer Center

Miami Beach, Florida, 33140

Recruiting

Oleg Gligich · Contact

Baptist Cancer Care - Plantation

Plantation, Florida, 33324

Recruiting

Lauren Carcas · Contact

St. Joseph's Women's Hospital

Tampa, Florida, 33607

Recruiting

Robert Gabordi · Contact

Rush Cancer Center

Chicago, Illinois, 60607

Recruiting

Ruta Rao · Contact

Deaconess Chancellor Center for Oncology

Newburgh, Indiana, 47630

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Samer Schuman · Contact

University of Kansas Cancer Center

Westwood, Kansas, 66205

Recruiting

Julia White · Contact

St. Elizabeth Edgewood Hospital

Edgewood, Kentucky, 41017

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Daniel Flora · Contact

Norton Cancer Institute - Downtown

Louisville, Kentucky, 40202

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John Hamm · Contact

Baptist Health Louisville

Louisville, Kentucky, 40207

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Mounika Mandadi · Contact

Weinberg Center at Mercy

Baltimore, Maryland, 21202

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David Riseberg · Contact

Greater Baltimore Medical Center

Baltimore, Maryland, 21204

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Robert Donegan · Contact

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215

Recruiting

Qiwei Gai · Contact

MedStar Georgetown Cancer Institute

Baltimore, Maryland, 21237

Recruiting

Shweta Kurian · Contact

The Center for Cancer and Blood Disorders - Bethesda

Bethesda, Maryland, 20818

Recruiting

Victor Priego · Contact

James M Stockman Cancer Institute

Frederick, Maryland, 21702

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Natalia Marina · Contact

Tate Cancer Center at UM Baltimore Washington

Glen Burnie, Maryland, 21061

Recruiting

Aaron Iddings · Contact

Meritus Center for Clinical Research

Hagerstown, Maryland, 21742

Recruiting

Victoria Giffi · Contact

Holy Cross Hospital - Silver Spring

Silver Spring, Maryland, 20910

Recruiting

Cheryl Aylesworth · Contact

University of Maryland St. Joseph Medical Center

Towson, Maryland, 21204

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Ethan Rogers · Contact

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805

Recruiting

Ragisha Gopalakrishnan · Contact

Metro Minnesota Community Oncology Consortium (MMCORC)

Saint Louis Park, Minnesota, 55426

Recruiting

Yan Ji · Contact

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111

Recruiting

Whitney Hensing · Contact

John Theurer Cancer Center

Hackensack, New Jersey, 07601

Recruiting

Deena Graham · Contact

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901

Recruiting

Mridula George · Contact

Stony Brook Medicine

Stony Brook, New York, 11794

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Alison Stopeck · Contact

Atrium Health Levine Cancer Institute

Charlotte, North Carolina, 28204

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Arielle Heeke · Contact

Novant Health Cancer Institute - Elizabeth

Charlotte, North Carolina, 28204

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Kimberly Strickland · Contact

FirstHealth Outpatient Cancer Center

Pinehurst, North Carolina, 28374

Recruiting

Charles Kuzma · Contact

UNC Cancer Care at Nash

Rocky Mount, North Carolina, 27804

Recruiting

Elie Choufani · Contact

Atrium Health Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157

Recruiting

Katherine Ansley · Contact

Aultman Timken Family Cancer Center

Canton, Ohio, 44710

Recruiting

Sunitha Vemulapalli · Contact

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195

Recruiting

Shimoli Barot · Contact

Penn State Health Medical Group - Andrews Patel

Harrisburg, Pennsylvania, 17111

Recruiting

Kumudini Rao · Contact

Penn State Cancer Institute

Hershey, Pennsylvania, 17033

Recruiting

Cristina Truica · Contact

UPMC Magee - Womens Hospital

Pittsburgh, Pennsylvania, 15213

Recruiting

Julia Foldi · Contact

Guthrie Sayre

Sayre, Pennsylvania, 18840

Recruiting

Mohammed Ziauddin · Contact

Women & Infants Hospital

Providence, Rhode Island, 02905

Recruiting

William Sikov · Contact

Spartanburg Medical Center

Spartanburg, South Carolina, 29303

Recruiting

Isaac Alwine · Contact

Avera Cancer Institute

Sioux Falls, South Dakota, 57105

Recruiting

Jason Jones · Contact

Ballad Health Cancer Center

Kingsport, Tennessee, 37660

Recruiting

Asheesh Shipstone · Contact

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting

Vincente Valero · Contact

Joe Arrington Cancer Research & Treatment Center

Lubbock, Texas, 79410

Recruiting

Ibrahim Shalaby · Contact

Alan B. Pearson Regional Cancer Center

Lynchburg, Virginia, 24501

Recruiting

Michael O'Neill · Contact

Bon Secours Cancer Institute at St. Francis

Midlothian, Virginia, 23114

Recruiting

William Irvin · Contact

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298

Recruiting

Elizabeth Barrows · Contact

WVU Cancer Institute

Morgantown, West Virginia, 26505

Recruiting

Sobha Kurian · Contact

Aurora Cancer Care - Wauwatosa

Wauwatosa, Wisconsin, 53226

Recruiting

Peter Polewski · Contact