OncoMatch/Clinical Trials/NCT07069595
PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease
Is NCT07069595 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Datopotamab deruxtecan for breast cancer.
Treatment: Datopotamab deruxtecan — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Required: ESR1 expression <10% (<10%)
ER/PR <10%
Required: PR (PGR) expression <10% (<10%)
ER/PR <10%
Required: HER2 (ERBB2) 0-1+ by IHC or 2+ by IHC and FISH negative (0-1+ by IHC or 2+ by IHC and FISH negative)
HER2 0-1+ by IHC or 2+ by IHC and fluorescence in situ hybridization (FISH) negative
Disease stage
Required: Stage II, III
Prior therapy
Must have received: neoadjuvant systemic therapy — neoadjuvant
Stage II/III TNBC treated with neoadjuvant systemic therapy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UNC Lineberger Comprehensive Cancer Center · Chapel Hill, North Carolina
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07069595 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received neoadjuvant systemic therapy.
Does this trial require ESR1?
Yes, ESR1 expression <10% is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR expression <10% is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 0-1+ by IHC or 2+ by IHC and FISH negative is a required biomarker for enrollment.
What disease stage is eligible?
Stage II or III is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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