Home › Breast Cancer › NCT07069595

PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease

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

Who can join

Ages 18 and older · All sexes

Inclusion 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.
* 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 Criteria:

• Participants are pregnant or breastfeeding.

About the study

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.

What is being tested

• Datopotamab deruxtecan (drug)
• Circulating tumor DNA (ctDNA) testing (diagnostic test)

Sponsor: UNC Lineberger Comprehensive Cancer Center · Participants: 78 · Started: Feb 26, 2026

Contact the study team

• Taylor Pierce · Phone: (919) 445-4827

Official record on ClinicalTrials.gov — NCT07069595

Locations in the U.S.

Conditions

• Breast Cancer
• Triple-Negative Breast Cancer

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.