PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease

ConditionsBreast Cancer Residual Disease Triple Negative Breast Cancer (TNBC)Stage II/III

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorUNC Lineberger Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

Datopotamab deruxtecan
Drug
Dato-DXd is administered adjuvantly at 6 mg/kg IV for eight cycles.
Circulating tumor DNA (ctDNA) testing
Diagnostic test
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.

Treatment groups

78 Participants

are divided into 1 treatment group

Group A: Patients with higher residual cancer burdenExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

The proportion of triple negative breast cancer (TNBC) with molecular residual disease (MRD)

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.

Time frame