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PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease

Study acronym: PREDICT-RD
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site contact updatedv8
  2. Site contact updatedv7
  3. Primary completion date: Nov 2028 to Nov 1, 2031
    • Study completion date: Nov 2028 to Nov 1, 2032
    v6
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2026 to Feb 26, 2026
    • Site details revised
    v5
  5. Start date: Nov 2025 to Jan 2026v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Sep 2025 to Nov 2025v3
  2. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07069595
Lead Sponsor UNC Lineberger Comprehensive Cancer Center
Collaborators: AstraZeneca, Translational Breast Cancer Research Consortium
Conditions
(from sponsor)		 Breast Cancer, Residual Disease, Triple Negative Breast Cancer (TNBC), Stage II/III
Related terms Breast Neoplasms, Neoplasm, Residual, Triple Negative Breast Neoplasms
Enrollment 78 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov