EXActDNA-003 / NSABP B-64: Study of Molecular Residual Disease Detection in Breast Cancer (MRD)
- Conditions
- Breast Cancer
- Interventions
- Diagnostic Test: ctDNA MRD test
- Registration Number
- NCT06401421
- Lead Sponsor
- Exact Sciences Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1800
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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.
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Histologically confirmed invasive carcinoma of the breast.
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Planned neoadjuvant therapy which includes cytotoxic chemotherapy.
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Tumor size ≥ 2.1 cm in greatest diameter.
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Unifocal or multifocal cancer documented to be the same histologic clinical subtype.
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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.)
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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.
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Available residual tissue from diagnostic biopsy from the breast or an involved ipsilateral lymph node for submission to create a bespoke ctDNA assay.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with High Risk Early Breast Cancer ctDNA MRD test Participants with High Risk Early Breast Cancer
- Primary Outcome Measures
Name Time Method Distant Recurrence Free Interval (dRFI) 6 years Core biopsy tissue evaluability rate 3 years
- Secondary Outcome Measures
Name Time Method Invasive breast cancer-free survival (IBCFS) 6 years Sensitivity/Specificity 6 years Prevalence of test positivity 6 years Recurrence-free interval (RFI) 6 years Event-free survival (EFS) 6 years Overall survival (OS) 6 years Lead Time 6 years Prevalence of tumor mutations and germline variants 6 years Pathologic complete response (pCR) status 6 years
Trial Locations
- Locations (42)
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
Lahey Hospital & Medical Center
🇺🇸Burlington, Massachusetts, United States
Penn State Health Medical Group - Andrews Patel
🇺🇸Harrisburg, Pennsylvania, United States
Penn State Cancer Institute
🇺🇸Hershey, Pennsylvania, United States
Maisonneuve-Rosemont Hospital (HMR)
🇨🇦Montréal, Quebec, Canada
Katmai Oncology Group - Anchorage
🇺🇸Anchorage, Alaska, United States
Stanford Cancer Institute
🇺🇸Palo Alto, California, United States
Kaiser Permanente Medical Center
🇺🇸Vallejo, California, 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
Rush Cancer Center
🇺🇸Chicago, Illinois, 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
Greater Baltimore Medical Center
🇺🇸Baltimore, Maryland, United States
MedStar Georgetown Cancer Institute
🇺🇸Baltimore, Maryland, United States
The Center for Cancer and Blood Disorders - Bethesda
🇺🇸Bethesda, Maryland, United States
Tate Cancer Center at UM Baltimore Washington
🇺🇸Glen Burnie, Maryland, United States
Holy Cross Hospital - Silver Spring
🇺🇸Silver Spring, Maryland, United States
University of Maryland St. Joseph Medical Center
🇺🇸Towson, Maryland, United States
Metro Minnesota Community Oncology Consortium (MMCORC)
🇺🇸Saint Louis Park, Minnesota, 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
FirstHealth Outpatient Cancer Center
🇺🇸Pinehurst, North Carolina, United States
UNC Cancer Care at Nash
🇺🇸Rocky Mount, North Carolina, United States
Aultman Timken Family Cancer Center
🇺🇸Canton, Ohio, United States
Cleveland Clinic Main Campus
🇺🇸Cleveland, Ohio, United States
UPMC Magee - Womens Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Women & Infants Hospital
🇺🇸Providence, Rhode Island, 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
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
Jewish General Hospital
🇨🇦Montréal, Quebec, Canada
McGill University Health - Glen Site
🇨🇦Montréal, Quebec, Canada
Hôpital du Saint-Sacrement
🇨🇦Québec City, Quebec, Canada