drugset / Trial / NCT07371585

Trastuzumab Deruxtecan in First-Line HER2-Positive Metastatic Breast Cancer With Proactive Toxicity Management

NCT07371585

NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, single arm, non-randomized, multicenter, phase 2 study assessing the efficacy and safety of T-DXd as first-line treatment in HER2-positive advanced/metastatic BC patients (N=300). The study integrates digital health tools for proactive toxicity management and potentially facilitate early detection of ILD/pneumonitis.

Timeline

Start
2026-02-18
Primary completion
2029-08-01
Completion
2030-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Trastuzumab deruxtecan Monoclonal antibody 5.4 mg/kg Intravenous
Background Pertuzumab Monoclonal antibody 420 mg Intravenous

Indications