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NCT06401421Not yet recruiting

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
Exact Sciences CorporationClinicalTrials.govdiagnostic test
Verified
Study focus
Disease/Condition
Breast Cancer
Drug/Device/Intervention
ctDNA MRD test
Study type
Observational
Intervention type
diagnostic test
Sponsor & location
Primary sponsor
Exact Sciences Corporation
Timeline & enrollment
Phase
N/A
Start date
May 01, 2024
End date
Apr 01, 2030
Enrollment
1800 participants
Primary outcome

Core biopsy tissue evaluability rate,Distant Recurrence Free Interval (dRFI)

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.

ICD-10 classifications
Malignant neoplasm of breastMalignant neoplasm of breastCarcinoma in situ of breast, unspecifiedMalignant neoplasm: Breast, unspecifiedOther carcinoma in situ of breast
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06401421
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06401421 through Pure Global AI's free database. This phase not specified trial is sponsored by Exact Sciences Corporation and is currently Not yet recruiting. The study focuses on Breast Cancer. Target enrollment is 1800 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.