PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease

This is a Phase II, interventional, prospective, single-arm, multi-center study that will enroll patients with stage II/III triple negative breast cancer (TNBC) who have residual cancer burden (RCB) II/III after conventional neoadjuvant chemo-immunotherapy followed by surgery. Technological advances in ctDNA assays have improved both the sensitivity and reliability of molecular residual disease (MRD) detection to enable real-time measurement with clinical-grade assays. The primary objective of this study will be to evaluate ctDNA-based MRD status in high-risk, early-stage TNBC patients by def

Trial Details

NCT ID

NCT07069595

Phase

PHASE2

Sponsor

UNC Lineberger Comprehensive Cancer Center

Status

RECRUITING

Cancer Type

Breast Cancer

Interventions

Datopotamab deruxtecan
Circulating tumor DNA (ctDNA) testing

Locations (sample)

Chapel Hill, North Carolina, United States|35.9132,-79.05584

Key Eligibility Criteria

Written informed consent was obtained to participate in the study, and HIPAA authorization for the release of personal health information.
Participant is willing and able to comply with study procedures based on the judgment of the investigator.
Age ≥ 18 years at the time of consent.
Histological confirmation of TNBC defined by ER/PR \<10%, HER2 0-1+ by IHC or 2+ by IHC and fluorescence in situ hybridization (FISH) negative.

For full eligibility, visit ClinicalTrials.gov.

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