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.
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Efficacy of T-DXd as a first-line therapy - TFST
Timeframe: From date of enrollment until the date of first documented progression, death, lost of follow-up, withdraw consent or the study is terminated by SOLTI, whichever occurs first, assessed up to approximately 60 months after the first patient enrolled
Health-related quality of life
Timeframe: From date of enrollment until the date of first documented progression, death, lost of follow-up, withdrawal of consent or the study is terminated by SOLTI, whichever occurs first, assessed up to approximately 60 months after the first patient enrolled.