RecruitingPhase 2NCT07069595

PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease

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

Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

78 participants

Start Date

Feb 26, 2026

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Residual Disease

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

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.
Stage II/III TNBC treated with neoadjuvant systemic therapy AND have residual disease defined as RCB II/III at time of surgery.
Baseline staging scans at the discretion of the treating physician and demonstrate no evidence of metastatic disease.
The participant must have archival diagnostic tissue and/or surgical resection tissue Available.
Participants are willing and able to comply with study procedures based on the judgment of the investigator.

Exclusion Criteria1

• Participants are pregnant or breastfeeding.

Interventions

DRUGDatopotamab deruxtecan

Dato-DXd is administered adjuvantly at 6 mg/kg IV for eight cycles.

DIAGNOSTIC_TESTCirculating 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.