RecruitingNCT06401421

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

Sponsor

Exact Sciences Corporation

Enrollment

1,800 participants

Start Date

Jun 7, 2024

Study Type

OBSERVATIONAL

Conditions

Breast Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a blood test that detects tiny fragments of tumor DNA (circulating tumor DNA or ctDNA) to find out if cancer is still present after neoadjuvant chemotherapy (chemo given before surgery) for breast cancer. The goal is to see if this test can identify who is at highest risk of cancer returning. **You may be eligible if...** - You are 18 or older - You have been diagnosed with invasive breast cancer with a tumor at least 2.1 cm in size - You are planned to receive neoadjuvant (pre-surgery) chemotherapy - You have certain high-risk breast cancer features (such as triple-negative, HER2-positive, or high-grade hormone receptor positive) - You are willing to provide blood samples (about 2.5 tablespoons per draw) **You may NOT be eligible if...** - Your cancer has already spread to distant organs - You have already started neoadjuvant chemotherapy - You have had another invasive cancer in the last 5 years - You are pregnant - You have had a prior solid organ transplant or stem cell transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTctDNA MRD test

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

Locations(58)

Katmai Oncology Group - Anchorage

Anchorage, Alaska, United States

Stanford Cancer Institute

Palo Alto, California, United States

Harbor-UCLA Medical Center - Hematology / Oncology

Torrance, California, United States

Kaiser Permanente Medical Center

Vallejo, California, United States

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

Aurora, Colorado, United States

AdventHealth East Altamonte Oncology and Hematology

Altamonte Springs, Florida, United States

Mount Sinai Medical - Comprehensive Cancer Center

Miami Beach, Florida, United States

Baptist Cancer Care - Plantation

Plantation, Florida, United States

St. Joseph's Women's Hospital

Tampa, Florida, United States

Rush Cancer Center

Chicago, Illinois, United States

Deaconess Chancellor Center for Oncology

Newburgh, Indiana, United States

University of Kansas Cancer Center

Westwood, Kansas, United States

St. Elizabeth Edgewood Hospital

Edgewood, Kentucky, United States

Norton Cancer Institute - Downtown

Louisville, Kentucky, United States

Baptist Health Louisville

Louisville, Kentucky, United States

Weinberg Center at Mercy

Baltimore, Maryland, United States

Greater Baltimore Medical Center

Baltimore, Maryland, United States

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

MedStar Georgetown Cancer Institute

Baltimore, Maryland, United States

The Center for Cancer and Blood Disorders - Bethesda

Bethesda, Maryland, United States

James M Stockman Cancer Institute

Frederick, Maryland, United States

Tate Cancer Center at UM Baltimore Washington

Glen Burnie, Maryland, United States

Meritus Center for Clinical Research

Hagerstown, Maryland, United States

Holy Cross Hospital - Silver Spring

Silver Spring, Maryland, United States

University of Maryland St. Joseph Medical Center

Towson, Maryland, United States

Lahey Hospital & Medical Center

Burlington, Massachusetts, United States

Metro Minnesota Community Oncology Consortium (MMCORC)

Saint Louis Park, Minnesota, United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

John Theurer Cancer Center

Hackensack, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Stony Brook Medicine

Stony Brook, New York, United States

Atrium Health Levine Cancer Institute

Charlotte, North Carolina, United States

Novant Health Cancer Institute - Elizabeth

Charlotte, North Carolina, United States

FirstHealth Outpatient Cancer Center

Pinehurst, North Carolina, United States

UNC Cancer Care at Nash

Rocky Mount, North Carolina, United States

Atrium Health Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Aultman Timken Family Cancer Center

Canton, Ohio, United States

Cleveland Clinic Main Campus

Cleveland, Ohio, United States

Penn State Health Medical Group - Andrews Patel

Harrisburg, Pennsylvania, United States

Penn State Cancer Institute

Hershey, Pennsylvania, United States

UPMC Magee - Womens Hospital

Pittsburgh, Pennsylvania, United States

Guthrie Sayre

Sayre, Pennsylvania, United States

Women & Infants Hospital

Providence, Rhode Island, United States

Spartanburg Medical Center

Spartanburg, South Carolina, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Ballad Health Cancer Center

Kingsport, Tennessee, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Joe Arrington Cancer Research & Treatment Center

Lubbock, Texas, United States

Alan B. Pearson Regional Cancer Center

Lynchburg, Virginia, United States

Bon Secours Cancer Institute at St. Francis

Midlothian, Virginia, United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

WVU Cancer Institute

Morgantown, West Virginia, United States

Aurora Cancer Care - Wauwatosa

Wauwatosa, Wisconsin, United States

Maisonneuve-Rosemont Hospital (HMR)

Montreal, Quebec, Canada

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

McGill University Health - Glen Site

Montreal, Quebec, Canada

Hôpital du Saint-Sacrement

Québec, Quebec, Canada

View Full Details on ClinicalTrials.gov

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NCT06401421

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