NCT07069595RecruitingPhase 2
PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease
PREDICT-RD: Postoperative Molecular Residual Disease by ctDNA Surveillance in TNBC With Residual Disease
Source: ClinicalTrials.gov · Last updated 22 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 78 (estimated)
- First submitted
- 7 Jul 2025
- Start date
- 26 Feb 2026
- Primary completion date
- 1 Nov 2031
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT07069595
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 78
- From 26 Feb 2026 to the primary completion date, 1 Nov 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Participants are pregnant or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UNC Lineberger Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.