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EXActDNA-003 / NSABP B-64: Study of Molecular Residual Disease Detection in Breast Cancer (MRD) - Trial NCT06401421

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.

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NCT06401421
Not yet recruiting
diagnostic test
Trial Details
ClinicalTrials.gov โ€ข NCT06401421
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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

Study Focus

Breast Cancer

ctDNA MRD test

Observational

diagnostic test

Sponsor & Location

Exact Sciences Corporation

Timeline & Enrollment

N/A

May 01, 2024

Apr 01, 2030

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 breast
Malignant neoplasm of breast
Carcinoma in situ of breast, unspecified
Malignant neoplasm: Breast, unspecified
Other carcinoma in situ of breast

Data Source

ClinicalTrials.gov

NCT06401421

Non-Device Trial