PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT07069595
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Datopotamab deruxtecan — DRUG
    Dato-DXd is administered adjuvantly at 6 mg/kg IV for eight cycles.
  • 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.

Study Details

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.

Key Dates

Start date
Feb 26, 2026
Status verified
Apr 2026
Primary completion
Nov 1, 2031
Completion
Nov 1, 2032

Study Design

Enrollment
78 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients with higher residual cancer burden
    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.

Primary Outcome Measure

The proportion of triple negative breast cancer (TNBC) with molecular residual disease (MRD) [ Time Frame: Up to 3 years after registration ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27514
Ana Gallegos
[email protected]
919-445-4827
Taylor Pierce
[email protected]
(919) 445-4827
Yara Abdou, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chapel Hill, NC

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
UNC Lineberger Comprehensive Cancer Center· Chapel Hill, NC

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