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

NCT06401421 | Recruiting FDA Device

• 1 other identifier: 2023-05
• Study Type: observational
• Target: 1,800
• Locations: 2 countries
• Sites: 58

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

Keywords

Breast Cancer; ctDNA

Outcome Measures

Primary Outcomes (2)

• Core biopsy tissue evaluability rate

  3 years

• Distant Recurrence Free Interval (dRFI)

  6 years

Secondary Outcomes (9)

• 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

Study Arms (1)

Participants with High Risk Early Breast Cancer

Participants with High Risk Early Breast Cancer

Diagnostic Test: ctDNA MRD test

Interventions

ctDNA MRD test DIAGNOSTIC_TEST

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

Also known as: Oncodetect™

Participants with High Risk Early Breast Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.
• 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:
• 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.)
• 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.

You may not qualify if:

• 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.
• Known pregnancy at time of enrollment.
• Prior solid organ transplant.
• Prior allogeneic hematopoietic stem cell transplant.

Sponsors & Collaborators

• Exact Sciences Corporation: lead
• NSABP Foundation Inc: collaborator

Study Sites (58)

Katmai Oncology Group - Anchorage

Anchorage, Alaska, 99508, United States

RECRUITING

Stanford Cancer Institute

Palo Alto, California, 94304, United States

RECRUITING

Harbor-UCLA Medical Center - Hematology / Oncology

Torrance, California, 90502, United States

RECRUITING

Kaiser Permanente Medical Center

Vallejo, California, 94589, United States

RECRUITING

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

Aurora, Colorado, 80045, United States

RECRUITING

AdventHealth East Altamonte Oncology and Hematology

Altamonte Springs, Florida, 32701, United States

RECRUITING

Mount Sinai Medical - Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

RECRUITING

Baptist Cancer Care - Plantation

Plantation, Florida, 33324, United States

RECRUITING

St. Joseph's Women's Hospital

Tampa, Florida, 33607, United States

RECRUITING

Rush Cancer Center

Chicago, Illinois, 60607, United States

RECRUITING

Deaconess Chancellor Center for Oncology

Newburgh, Indiana, 47630, United States

RECRUITING

University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

RECRUITING

St. Elizabeth Edgewood Hospital

Edgewood, Kentucky, 41017, United States

RECRUITING

Norton Cancer Institute - Downtown

Louisville, Kentucky, 40202, United States

RECRUITING

Baptist Health Louisville

Louisville, Kentucky, 40207, United States

RECRUITING

Weinberg Center at Mercy

Baltimore, Maryland, 21202, United States

RECRUITING

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

RECRUITING

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

RECRUITING

MedStar Georgetown Cancer Institute

Baltimore, Maryland, 21237, United States

RECRUITING

The Center for Cancer and Blood Disorders - Bethesda

Bethesda, Maryland, 20818, United States

RECRUITING

James M Stockman Cancer Institute

Frederick, Maryland, 21702, United States

RECRUITING

Tate Cancer Center at UM Baltimore Washington

Glen Burnie, Maryland, 21061, United States

RECRUITING

Meritus Center for Clinical Research

Hagerstown, Maryland, 21742, United States

RECRUITING

Holy Cross Hospital - Silver Spring

Silver Spring, Maryland, 20910, United States

RECRUITING

University of Maryland St. Joseph Medical Center

Towson, Maryland, 21204, United States

RECRUITING

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805, United States

RECRUITING

Metro Minnesota Community Oncology Consortium (MMCORC)

Saint Louis Park, Minnesota, 55426, United States

RECRUITING

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

RECRUITING

John Theurer Cancer Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

RECRUITING

Stony Brook Medicine

Stony Brook, New York, 11794, United States

RECRUITING

Atrium Health Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

Novant Health Cancer Institute - Elizabeth

Charlotte, North Carolina, 28204, United States

RECRUITING

FirstHealth Outpatient Cancer Center

Pinehurst, North Carolina, 28374, United States

RECRUITING

UNC Cancer Care at Nash

Rocky Mount, North Carolina, 27804, United States

RECRUITING

Atrium Health Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Aultman Timken Family Cancer Center

Canton, Ohio, 44710, United States

RECRUITING

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

RECRUITING

Penn State Health Medical Group - Andrews Patel

Harrisburg, Pennsylvania, 17111, United States

RECRUITING

Penn State Cancer Institute

Hershey, Pennsylvania, 17033, United States

RECRUITING

UPMC Magee - Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Guthrie Sayre

Sayre, Pennsylvania, 18840, United States

RECRUITING

Women & Infants Hospital

Providence, Rhode Island, 02905, United States

RECRUITING

Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States

RECRUITING

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

RECRUITING

Ballad Health Cancer Center

Kingsport, Tennessee, 37660, United States

RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Joe Arrington Cancer Research & Treatment Center

Lubbock, Texas, 79410, United States

RECRUITING

Alan B. Pearson Regional Cancer Center

Lynchburg, Virginia, 24501, United States

RECRUITING

Bon Secours Cancer Institute at St. Francis

Midlothian, Virginia, 23114, United States

RECRUITING

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298, United States

RECRUITING

WVU Cancer Institute

Morgantown, West Virginia, 26505, United States

RECRUITING

Aurora Cancer Care - Wauwatosa

Wauwatosa, Wisconsin, 53226, United States

RECRUITING

Maisonneuve-Rosemont Hospital (HMR)

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

RECRUITING

McGill University Health - Glen Site

Montreal, Quebec, Canada

RECRUITING

Hôpital du Saint-Sacrement

Québec, Quebec, G1S 4L8, Canada

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

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

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 6, 2024
• Study Start: June 7, 2024
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available from 2 years and ending 4 years after publication
• 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.

Locations

US (53); CA (5)