EXActDNA-003 / NSABP B-64: Study of Molecular Residual Disease Detection in Breast Cancer (MRD)
NCT ID: NCT06401421
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
1800 participants
OBSERVATIONAL
2024-06-07
2030-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Participants will be followed for up to 5.5 years.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Chemotherapy Monitoring by ctDNA in HER2- Metastatic Breast Cancer
NCT04720729
A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population
NCT05708235
Adopting the MRD Strategy to Optimize Post-operation Adjuvant Therapies for Early Stage Breast Cancer
NCT05345860
Detecting Tumor DNA in the Blood of HR+/HER2-low Metastatic Breast Cancer Patients to Find Candidates for T-DXd Therapy
NCT06680596
Genetic Testing in Predicting Tumor Response in Patients With Stage I-III HER2 Negative Invasive Breast Cancer
NCT01334021
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Participants with High Risk Early Breast Cancer
Participants with High Risk Early Breast Cancer
ctDNA MRD test
Blood and tissue samples will be collected for the ctDNA MRD test
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ctDNA MRD test
Blood and tissue samples will be collected for the ctDNA MRD test
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NSABP Foundation Inc
NETWORK
Exact Sciences Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
NSABP Department of Site and Study Management Department of Site and Study Management
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Theodore Kim
Role: primary
Irene Wapnir
Role: primary
Jennifer Lee
Role: primary
Samantha Seaward
Role: primary
Marie Wood
Role: primary
Wassim Mchayleh
Role: primary
Oleg Gligich
Role: primary
Lauren Carcas
Role: primary
Robert Gabordi
Role: primary
Ruta Rao
Role: primary
Samer Schuman
Role: primary
Julia White
Role: primary
Daniel Flora
Role: primary
John Hamm
Role: primary
Mounika Mandadi
Role: primary
David Riseberg
Role: primary
Robert Donegan
Role: primary
Qiwei Gai
Role: primary
Shweta Kurian
Role: primary
Victor Priego
Role: primary
Natalia Marina
Role: primary
Aaron Iddings
Role: primary
Victoria Giffi
Role: primary
Cheryl Aylesworth
Role: primary
Ethan Rogers
Role: primary
Ragisha Gopalakrishnan
Role: primary
Yan Ji
Role: primary
Whitney Hensing
Role: primary
Deena Graham
Role: primary
Mridula George
Role: primary
Alison Stopeck
Role: primary
Arielle Heeke
Role: primary
Kimberly Strickland
Role: primary
Charles Kuzma
Role: primary
Elie Choufani
Role: primary
Katherine Ansley
Role: primary
Sunitha Vemulapalli
Role: primary
Shimoli Barot
Role: primary
Kumudini Rao
Role: primary
Cristina Truica
Role: primary
Julia Foldi
Role: primary
Mohammed Ziauddin
Role: primary
William Sikov
Role: primary
Isaac Alwine
Role: primary
Jason Jones
Role: primary
Asheesh Shipstone
Role: primary
Vincente Valero
Role: primary
Ibrahim Shalaby
Role: primary
Michael O'Neill
Role: primary
William Irvin
Role: primary
Elizabeth Barrows
Role: primary
Sobha Kurian
Role: primary
Peter Polewski
Role: primary
Lucas Sideris
Role: primary
Erica Patocskai
Role: primary
Mark Basik
Role: primary
Nathaniel Bouganim
Role: primary
Dominique Boudreau
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-05
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.