PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease

NCT07069595 | Recruiting Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: LCCC2215
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

circulating tumor DNA (ctDNA); surveillance; Dato-DXd

Outcome Measures

Primary Outcomes (1)

• The proportion of triple negative breast cancer (TNBC) with molecular residual disease (MRD)

  The number of participants with triple negative breast cancer (TNBC) with molecular residual disease (MRD) only recurrence, which is defined as ctDNA positivity without radiographically measurable recurrence, during post-surgery surveillance.

  Up to 3 years after registration

Secondary Outcomes (8)

• The time between Circulating tumor DNA (ctDNA) positivity and clinically proven relapse

  Up to 3 years after registration

• Duration of Circulating tumor DNA (ctDNA) clearance

  Up to 3 years after registration

• Circulating tumor DNA (ctDNA) clearance with Dato-DXd

  Up to 3 years after registration

• Toxicity of Dato-DXd

  Up to 3 years after registration

• Recurrence Free Survival (RFS) for ctDNA-positive and ctDNA-negative disease.

  Up to 3 years after registration

Study Arms (1)

Patients with higher residual cancer burden

EXPERIMENTAL

Participants with stage II/III triple negative breast cancer (TNBC) and residual disease post-neoadjuvant therapy, particularly patients with higher residual cancer burden (RCB II/III), remain at high risk for developing recurrence.

Drug: Datopotamab deruxtecan; Diagnostic Test: Circulating tumor DNA (ctDNA) testing

Interventions

Datopotamab deruxtecan DRUG

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

Also known as: Dato-DXd

Patients with higher residual cancer burden

Circulating tumor DNA (ctDNA) testing DIAGNOSTIC_TEST

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.

Patients with higher residual cancer burden

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participants are pregnant or breastfeeding.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• AstraZeneca: collaborator
• Translational Breast Cancer Research Consortium: collaborator

Study Sites (1)

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm, Residual; Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yara Abdou, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Taylor Pierce

CONTACT

(919) 445-4827; Taylor_Pierce@med.unc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 16, 2025
• Study Start: February 26, 2026
• Primary Completion (Estimated): November 1, 2031
• Study Completion (Estimated): November 1, 2032
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)