Actively Recruiting
Clinical Validation Study of ctDNA to Predict Recurrence in High-Risk Early Breast Cancer Treated With Neoadjuvant Therapy
Led by Exact Sciences Corporation · Updated on 2026-01-20
1800
Participants Needed
58
Research Sites
N/A
Total Duration
On this page
Sponsors
E
Exact Sciences Corporation
Lead Sponsor
N
NSABP Foundation Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a method to detect molecular residual disease (MRD) in people with high-risk early breast cancer undergoing chemotherapy. This observational study aims to predict cancer recurrence by analyzing circulating tumor DNA (ctDNA) from blood and tissue samples. Participants will be followed for up to 5.5 years to better understand the presence of tumor DNA after treatment and its relation to cancer outcomes. The study involves collecting blood and tissue samples to perform a ctDNA MRD test. Participants must have a confirmed invasive breast cancer planned for neoadjuvant chemotherapy, with tumors 2.1 cm or larger and certain clinical subtypes or risk factors. Residual tissue from diagnostic biopsies will be used to create personalized ctDNA assays. No experimental treatment is given; instead, participants are observed to assess test accuracy and disease recurrence. During the study, participants will provide blood samples totaling 34 cc at research visits and submit available biopsy tissue. Researchers will evaluate tissue sample quality and track distant recurrence-free intervals over six years. Various outcomes such as tumor mutation prevalence, test sensitivity, survival rates, and time to recurrence will be measured. The study's long-term follow-up allows close monitoring of disease status and patient health.
CONDITIONS
Brief Title
EXActDNA-003 / NSABP B-64: Study of Molecular Residual Disease Detection in Breast Cancer (MRD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant or authorized representative provides informed consent.
- Participant is 18 years of age or older.
- ECOG performance status of 0 or 1.
- Histologically confirmed invasive breast carcinoma.
- Planned neoadjuvant therapy including cytotoxic chemotherapy.
- Tumor size 2.1 cm or greater in greatest diameter.
- Unifocal or multifocal cancer of the same histologic clinical subtype.
- Clinically node positive, or if node negative, meets specific subtype or risk criteria including triple-negative, HER2+, or high-risk HR+/HER2-negative.
- Willing and able to comply with study requirements, including blood collection.
- Available residual tissue from diagnostic biopsy for ctDNA assay creation.
You will not qualify if you...
- Evidence of metastatic disease.
- Started neoadjuvant therapy for current breast cancer.
- Diagnosis of another invasive cancer at the same time, except non-melanoma skin cancer.
- Completed therapy for previous invasive cancer less than 5 years ago, except noninvasive carcinomas with definitive treatment.
- Completed therapy for prior hematologic malignancy less than 5 years ago.
- Multicentric or contralateral invasive breast cancers.
- Known pregnancy at enrollment.
- Prior solid organ transplant.
- Prior allogeneic hematopoietic stem cell transplant.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Initial assessment at enrollment
Participants provide blood and tissue samples for the ctDNA MRD test to assess molecular residual disease.
1 visit (in-person)
Duration - Up to 6 years
Participants are monitored over several years to evaluate recurrence and survival outcomes.
Periodic visits over 6 years
Trial Site Locations
Total: 58 locations
1
Katmai Oncology Group - Anchorage
Anchorage, Alaska, United States, 99508
Actively Recruiting
2
Stanford Cancer Institute
Palo Alto, California, United States, 94304
Actively Recruiting
3
Harbor-UCLA Medical Center - Hematology / Oncology
Torrance, California, United States, 90502
Actively Recruiting
4
Kaiser Permanente Medical Center
Vallejo, California, United States, 94589
Actively Recruiting
5
UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
6
AdventHealth East Altamonte Oncology and Hematology
Altamonte Springs, Florida, United States, 32701
Actively Recruiting
7
Mount Sinai Medical - Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
Actively Recruiting
8
Baptist Cancer Care - Plantation
Plantation, Florida, United States, 33324
Actively Recruiting
9
St. Joseph's Women's Hospital
Tampa, Florida, United States, 33607
Actively Recruiting
10
Rush Cancer Center
Chicago, Illinois, United States, 60607
Actively Recruiting
11
Deaconess Chancellor Center for Oncology
Newburgh, Indiana, United States, 47630
Actively Recruiting
12
University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
13
St. Elizabeth Edgewood Hospital
Edgewood, Kentucky, United States, 41017
Actively Recruiting
14
Norton Cancer Institute - Downtown
Louisville, Kentucky, United States, 40202
Actively Recruiting
15
Baptist Health Louisville
Louisville, Kentucky, United States, 40207
Actively Recruiting
16
Weinberg Center at Mercy
Baltimore, Maryland, United States, 21202
Actively Recruiting
17
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
Actively Recruiting
18
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Actively Recruiting
19
MedStar Georgetown Cancer Institute
Baltimore, Maryland, United States, 21237
Actively Recruiting
20
The Center for Cancer and Blood Disorders - Bethesda
Bethesda, Maryland, United States, 20818
Actively Recruiting
21
James M Stockman Cancer Institute
Frederick, Maryland, United States, 21702
Actively Recruiting
22
Tate Cancer Center at UM Baltimore Washington
Glen Burnie, Maryland, United States, 21061
Actively Recruiting
23
Meritus Center for Clinical Research
Hagerstown, Maryland, United States, 21742
Actively Recruiting
24
Holy Cross Hospital - Silver Spring
Silver Spring, Maryland, United States, 20910
Actively Recruiting
25
University of Maryland St. Joseph Medical Center
Towson, Maryland, United States, 21204
Actively Recruiting
26
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States, 01805
Actively Recruiting
27
Metro Minnesota Community Oncology Consortium (MMCORC)
Saint Louis Park, Minnesota, United States, 55426
Actively Recruiting
28
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Actively Recruiting
29
John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
30
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
31
Stony Brook Medicine
Stony Brook, New York, United States, 11794
Actively Recruiting
32
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
33
Novant Health Cancer Institute - Elizabeth
Charlotte, North Carolina, United States, 28204
Actively Recruiting
34
FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina, United States, 28374
Actively Recruiting
35
UNC Cancer Care at Nash
Rocky Mount, North Carolina, United States, 27804
Actively Recruiting
36
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
37
Aultman Timken Family Cancer Center
Canton, Ohio, United States, 44710
Actively Recruiting
38
Cleveland Clinic Main Campus
Cleveland, Ohio, United States, 44195
Actively Recruiting
39
Penn State Health Medical Group - Andrews Patel
Harrisburg, Pennsylvania, United States, 17111
Actively Recruiting
40
Penn State Cancer Institute
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
41
UPMC Magee - Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
42
Guthrie Sayre
Sayre, Pennsylvania, United States, 18840
Actively Recruiting
43
Women & Infants Hospital
Providence, Rhode Island, United States, 02905
Actively Recruiting
44
Spartanburg Medical Center
Spartanburg, South Carolina, United States, 29303
Actively Recruiting
45
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
46
Ballad Health Cancer Center
Kingsport, Tennessee, United States, 37660
Actively Recruiting
47
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
48
Joe Arrington Cancer Research & Treatment Center
Lubbock, Texas, United States, 79410
Actively Recruiting
49
Alan B. Pearson Regional Cancer Center
Lynchburg, Virginia, United States, 24501
Actively Recruiting
50
Bon Secours Cancer Institute at St. Francis
Midlothian, Virginia, United States, 23114
Actively Recruiting
51
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
52
WVU Cancer Institute
Morgantown, West Virginia, United States, 26505
Actively Recruiting
53
Aurora Cancer Care - Wauwatosa
Wauwatosa, Wisconsin, United States, 53226
Actively Recruiting
54
Maisonneuve-Rosemont Hospital (HMR)
Montreal, Quebec, Canada, H1T 2M4
Actively Recruiting
55
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2X 3E4
Actively Recruiting
56
Jewish General Hospital
Montreal, Quebec, Canada, H3T1E2
Actively Recruiting
57
McGill University Health - Glen Site
Montreal, Quebec, Canada
Actively Recruiting
58
Hôpital du Saint-Sacrement
Québec, Quebec, Canada, G1S 4L8
Actively Recruiting
Research Team
N
NSABP Department of Site and Study Management Department of Site and Study Management
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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