Recruiting
Phase 2

Dato-DXd

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT07069595

Conditions

Breast Cancer

Residual Disease

Triple Negative Breast Cancer (TNBC)

Stage II/III

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Datopotamab deruxtecan

Circulating tumor DNA (ctDNA) testing

Study Details

Brief 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.

Conditions

Breast Cancer

Residual Disease

Triple Negative Breast Cancer (TNBC)

Stage II/III

Study ID

NCT07069595

Start date

Feb 26, 2026

Status verified date

Apr, 2026

Completion date

Nov 1, 2032

Anticipated

Primary completion date

Nov 1, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

78 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Patients with higher residual cancer burden

Participants with stage II/III triple negative breast cancer (TNBC) and residual disease post-neoadjuvant therapy, particularly patients with higher residual cancer burden (RCB II/III), remain at high risk for developing recurrence.

Interventions

Datopotamab deruxtecan

Dato-DXd is administered adjuvantly at 6 mg/kg IV for eight cycles.

Circulating tumor DNA (ctDNA) testing

Circulating tumor DNA (ctDNA) testing is a type of biopsy that analyzes fragments of DNA shed by cancer cells into the bloodstream. These fragments, known as ctDNA, can provide valuable information about the genetic makeup of a tumor without needing a traditional tissue biopsy.

Primary outcome measure

  • The proportion of triple negative breast cancer (TNBC) with molecular residual disease (MRD) [ Time Frame: Up to 3 years after registration ]

Central Contacts and Locations

Central contacts

Taylor Pierce

(919) 445-4827Taylor_Pierce@med.unc.edu

Locations

UNC Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Ana Gallegos

919-445-4827ana_gallegos@med.unc.edu

Taylor Pierce

(919) 445-4827tepierce@email.unc.edu

Principal Investigator:

Yara Abdou, MD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Keywords

  • circulating tumor DNA (ctDNA)
  • surveillance
  • Dato-DXd

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-04-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.