ctDNA surveillance with Dato-DXd for people with high-risk early triple-negative breast cancer and residual disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.