Trials / Recruiting
RecruitingNCT06401421
EXActDNA-003 / NSABP B-64: Study of Molecular Residual Disease Detection in Breast Cancer (MRD)
EXActDNA-003 / NSABP B-64: Breast Cancer Clinical Validation Study to Predict Recurrence of High-Risk Early Breast Cancer Treated With Neoadjuvant Therapy Using a Bespoke Circulating Tumor DNA Assay to Detect Molecular Residual Disease
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,800 (estimated)
- Sponsor
- Exact Sciences Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | ctDNA MRD test | Blood and tissue samples will be collected for the ctDNA MRD test |
Timeline
- Start date
- 2024-06-07
- Primary completion
- 2030-04-01
- Completion
- 2030-04-01
- First posted
- 2024-05-06
- Last updated
- 2026-01-20
Locations
58 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06401421. Inclusion in this directory is not an endorsement.