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

Recruiting now

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT06401421

Run by

Exact Sciences Corporation

People needed

1800

Starts

2024-06-07

Expected to finish

2030-04-01

Last updated by the study team

2026-01-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Stanford Cancer Institute — Palo Alto, California, United States (enrolling)
• Harbor-UCLA Medical Center - Hematology / Oncology — Torrance, California, United States (enrolling)
• Kaiser Permanente Medical Center — Vallejo, California, United States (enrolling)
• UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center — Aurora, Colorado, United States (enrolling)
• AdventHealth East Altamonte Oncology and Hematology — Altamonte Springs, Florida, United States (enrolling)
• Mount Sinai Medical - Comprehensive Cancer Center — Miami Beach, Florida, United States (enrolling)
• Baptist Cancer Care - Plantation — Plantation, Florida, United States (enrolling)
• St. Joseph's Women's Hospital — Tampa, Florida, United States (enrolling)
• Rush Cancer Center — Chicago, Illinois, United States (enrolling)
• Deaconess Chancellor Center for Oncology — Newburgh, Indiana, United States (enrolling)
• University of Kansas Cancer Center — Westwood, Kansas, United States (enrolling)
• St. Elizabeth Edgewood Hospital — Edgewood, Kentucky, United States (enrolling)
• Norton Cancer Institute - Downtown — Louisville, Kentucky, United States (enrolling)
• Baptist Health Louisville — Louisville, Kentucky, United States (enrolling)
• Weinberg Center at Mercy — Baltimore, Maryland, United States (enrolling)
• Greater Baltimore Medical Center — Baltimore, Maryland, United States (enrolling)
• Sinai Hospital of Baltimore — Baltimore, Maryland, United States (enrolling)
• MedStar Georgetown Cancer Institute — Baltimore, Maryland, United States (enrolling)
• The Center for Cancer and Blood Disorders - Bethesda — Bethesda, Maryland, United States (enrolling)
• James M Stockman Cancer Institute — Frederick, Maryland, United States (enrolling)
• Tate Cancer Center at UM Baltimore Washington — Glen Burnie, Maryland, United States (enrolling)
• Meritus Center for Clinical Research — Hagerstown, Maryland, United States (enrolling)
• Holy Cross Hospital - Silver Spring — Silver Spring, Maryland, United States (enrolling)
• University of Maryland St. Joseph Medical Center — Towson, Maryland, United States (enrolling)
• Katmai Oncology Group - Anchorage — Anchorage, Alaska, United States (enrolling)

Full record on ClinicalTrials.gov

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