NCT07069595

PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease

PREDICT-RD: Postoperative Molecular Residual Disease by ctDNA Surveillance in TNBC With Residual Disease

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Despite treatment advances, patients with II/III triple negative breast cancer (TNBC) residual disease post-neoadjuvant therapy, particularly patients with higher residual cancer burden (RCB II/III), remain at high risk for developing recurrence. Furthermore, early detection of relapse risk, when the residual disease burden is micrometastatic (defined here as undetectable by standard cross-sectional imaging), provides a chance for disease eradication whereas macrometastatic disease (i.e., detectable on standard cross-sectional imaging) is generally considered to be non-curable. There are no standard of care (SOC) surveillance strategies for early detection of micrometastatic disease in high-risk TNBC beyond clinical monitoring. Detecting molecular residual disease (MRD) is a promising approach to identifying patients at increased risk of recurrence after definitive therapy, who may benefit from the escalation of their treatment and remain potentially curable with effective systemic therapy.

Conditions

• Breast Cancer
• Residual Disease
• Triple Negative Breast Cancer (TNBC)
• Stage II/III

Interventions

Type	Name	Description
DRUG	Datopotamab deruxtecan	Dato-DXd is administered adjuvantly at 6 mg/kg IV for eight cycles.
DIAGNOSTIC_TEST	Circulating tumor DNA (ctDNA) testing	Circulating tumor DNA (ctDNA) testing is a type of biopsy that analyzes fragments of DNA shed by cancer cells into the bloodstream. These fragments, known as ctDNA, can provide valuable information about the genetic makeup of a tumor without needing a traditional tissue biopsy.

Timeline

• Start date: 2026-02-26
• Primary completion: 2031-11-01
• Completion: 2032-11-01
• First posted: 2025-07-16
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study