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NCT07069595 · ClinicalTrials.gov registry record · Phase 2
PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease
A Phase 2 study of Breast Cancer and Triple Negative Breast Cancer (TNBC), sponsored by UNC Lineberger Comprehensive Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
- 1
- Study location
NCT07069595: Recruiting Phase 2 study of Breast Cancer and Triple Negative Breast Cancer (TNBC), sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT07069595 is a Phase 2 study of Breast Cancer and Triple Negative Breast Cancer (TNBC) that is actively recruiting participants, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 78 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07069595, a Phase 2 study of Breast Cancer and Triple Negative Breast Cancer (TNBC), is actively recruiting participants, sponsored by UNC Lineberger Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Datopotamab deruxtecan
- DIAGNOSTIC_TEST Circulating tumor DNA (ctDNA) testing
Study Locations (1)
North Carolina
- UNC Lineberger Comprehensive Cancer Center - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2026-02-26 |
| Est. Completion | 2032-11-01 |
| Phase | Phase 2 |
What NCT07069595 shows while recruiting
NCT07069595 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower).
The record links to 4 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Datopotamab deruxtecan is the first listed.
NCT07069595 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT07069595 about?
NCT07069595 is a clinical study titled "PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease". 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...
What is the current status of trial NCT07069595?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2026-02-26. Estimated completion is 2032-11-01.
What conditions does trial NCT07069595 study?
This clinical trial studies the following conditions: Breast Cancer, Triple Negative Breast Cancer (TNBC), Residual Disease, Stage II/III.
What interventions are being tested in trial NCT07069595?
The interventions under investigation include: Datopotamab deruxtecan (DRUG), Circulating tumor DNA (ctDNA) testing (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT07069595?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07069595 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07069595's enrollment target sits among peer trials
78 662nd of 1224 higher than 556 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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