NCT06401421 · Exact Sciences Corporation
EXActDNA-003 / NSABP B-64: Study of Molecular Residual Disease Detection in Breast Cancer (MRD)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Anchorage, Alaska
- Palo Alto, California
- Torrance, California
- Vallejo, California
- Aurora, Colorado
- Altamonte Springs, Florida
- Miami Beach, Florida
- Plantation, Florida
- Tampa, Florida
- Chicago, Illinois
- Newburgh, Indiana
- Westwood, Kansas
And 36 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 20, 2026 · Source of record for eligibility and locations