Actively Recruiting
PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2026-04-22
78
Participants Needed
1
Research Sites
348 weeks
Total Duration
On this page
Sponsors
U
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 defining the proportion of TNBC patients with MRD-only recurrence (ctDNA positive without radiographically measurable recurrence) during post-surgery surveillance. The secondary objectives will evaluate the safety, preliminary efficacy, and survival outcomes of using Dato-DXd in participants with MRD-only TNBC. Dato-DXd is an investigational antibody-drug conjugate (monoclonal antibody specific for TROP2 and a topoisomerase I (Topo-1) inhibitor) that has demonstrated promising efficacy in TNBC patients with a manageable safety profile.
CONDITIONS
Official Title
PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent and HIPAA authorization
- Willing and able to comply with study procedures
- Age 18 years or older at consent
- Histologically confirmed TNBC with ER/PR <10%, HER2 0-1+ by IHC or 2+ by IHC with negative FISH
- Stage II or III TNBC treated with neoadjuvant systemic therapy and residual disease defined as RCB II/III at surgery
- Baseline scans show no metastatic disease
- Archival diagnostic or surgical tissue available
- Willing and able to comply with study procedures per investigator judgment
You will not qualify if you...
- Pregnant or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
Research Team
T
Taylor Pierce
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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