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 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.

NCT Number	NCT07069595
Lead Sponsor	UNC Lineberger Comprehensive Cancer Center Collaborators: AstraZeneca, Translational Breast Cancer Research Consortium
Conditions	Breast Cancer, Residual Disease, Triple Negative Breast Cancer (TNBC), Stage II/III
Enrollment	78 participants
Start Date	2026-02-26
Primary Completion	2031-11-01 (estimated)
Study Completion	2032-11-01 (estimated)
Updated on ClinicalTrials.gov	2026-04-22