PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wyraźna zgoda na uczestnictwo w badaniu i autoryzacja dostępu do danych zdrowotnych
- •Wiek co najmniej 18 lat
- •Potwierdzony rozpoznaniem raka piersi typu TNBC (potrójnie ujemny)
- •Zaawansowany nowotwór (stopień II/III) leczone chemioterapią przed operacją
- •Obecność resztkowego nowotworu po operacji
- •Badania obrazowe (np. tomografia) pokazujące brak przerzutów
- •Dostępne próbki tkanki z rozpoznania lub z operacji
- •Zdolność i chęć do uczestnictwa w procedurach badania
✗ Disqualifies
- •Ciąża lub karmienie piersią
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- April 22, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, United States
Trial contact
Taylor Pierce
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.