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

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.

NCT Number	NCT07371585
Lead Sponsor	SOLTI Breast Cancer Research Group Collaborators: Westdeutsche Studiengruppe GmbH (WSG), UNICANCER
Conditions	Breast Cancer Stage IV
Enrollment	300 participants
Start Date	2026-02-18
Primary Completion	2029-08-01 (estimated)
Study Completion	2030-07-01 (estimated)
Updated on ClinicalTrials.gov	2026-03-27