Recruiting
OBSERVATIONAL
NCT06401421
EXActDNA-003 / NSABP B-64: Study of Molecular Residual Disease Detection in Breast Cancer (MRD)
View on ClinicalTrials.gov
Updated Dec 15, 2025
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.
Interventions
Name:
ctDNA MRD test
Type:
DIAGNOSTIC_TEST
Description:
Blood and tissue samples will be collected for the ctDNA MRD test
Primary Outcomes
Measure:
Core biopsy tissue evaluability rate
TimeFrame:
3 years
Description:
Measure:
Distant Recurrence Free Interval (dRFI)
TimeFrame:
6 years
Description:
Trial Information
NCT ID
NCT06401421
Status
Recruiting
Study Type
OBSERVATIONAL
Sponsor
Exact Sciences Corporation
Last Updated
December 15, 2025