drugset / Trial / NCT07371585
Trastuzumab Deruxtecan in First-Line HER2-Positive Metastatic Breast Cancer With Proactive Toxicity Management
Phase 2
Recruiting
300 enrolled
SOLTI Breast Cancer Research Group
UNICANCER · collabWestdeutsche Studiengruppe GmbH (WSG) · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trastuzumab deruxtecan | Monoclonal antibody | 5.4 mg/kg | Intravenous |
| Background | Pertuzumab | Monoclonal antibody | 420 mg | Intravenous |