ctDNA surveillance with Dato-DXd for people with high-risk early triple-negative breast cancer and residual disease
PREDICT-RD: Postoperative Molecular Residual Disease by ctDNA Surveillance in TNBC With Residual Disease
This study will test whether regular blood-based ctDNA monitoring can find tiny relapses in adults with stage II/III triple-negative breast cancer who have residual disease after neoadjuvant therapy and whether early treatment with Dato-DXd when ctDNA becomes positive can reduce recurrence.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT07069595 on ClinicalTrials.gov |
What this trial studies
This is a Phase II, prospective, single-arm study enrolling adults with stage II/III triple-negative breast cancer who have residual cancer burden (RCB II/III) after neoadjuvant chemo-immunotherapy and surgery. Participants will undergo serial blood-based ctDNA testing for molecular residual disease (MRD) during post-surgery surveillance to identify MRD-only recurrences that are not yet visible on imaging. Participants who develop ctDNA-only MRD will be offered the investigational antibody-drug conjugate datopotamab deruxtecan (Dato-DXd) and will be followed for safety, preliminary efficacy, and survival outcomes. The primary measure is the proportion of patients who experience MRD-only recurrence during the surveillance period, with secondary endpoints including treatment safety and longer-term outcomes.
Who should consider this trial
Good fit: Adults (≥18) with stage II/III triple-negative breast cancer who completed neoadjuvant therapy and surgery and have residual disease classified as RCB II or III with no evidence of metastatic disease are the intended candidates.
Not a fit: Patients with a pathologic complete response (no residual disease), existing radiographically detectable metastatic disease, or who are pregnant or breastfeeding are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the approach could catch relapse earlier when disease is microscopic and allow treatment with Dato-DXd that may lower the chance of overt metastatic recurrence.
How similar studies have performed: Blood-based ctDNA MRD surveillance has increasingly shown prognostic value and earlier trials suggest ADCs like datopotamab deruxtecan have activity in metastatic TNBC, but using ctDNA-guided Dato-DXd in the MRD setting is a novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: • Participants are pregnant or breastfeeding.
Where this trial is running
Chapel Hill, North Carolina
- UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Yara Abdou, MD — UNC Lineberger Comprehensive Cancer Center
- Study coordinator: Taylor Pierce
- Email: Taylor_Pierce@med.unc.edu
- Phone: (919) 445-4827
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.