DESTINY-B12: This Phase III trial is evaluating how safe and effective targeted therapy (Trastuzumab deruxtecan (T-DXd)) is in patients with advanced or metastatic HER2-positive breast cancer that has or has not spread to the brain.An Open-Label, Multinational, Multicenter, Phase 3b/4 Study of Trastuzumab Deruxtecan in Patients With or Without Baseline Brain Metastasis With Previously Treated Advanced/Metastatic HER2-Positive Breast Cancer (DESTINY-Breast12)

Summary

This is a non-randomised trial with two cohorts that both receive the same treatment. Patients will be enrolled into cohorts according to the presence or absence of brain metastases at baseline. Cohort 1 will include participants without BM at baseline and Cohort 2 will consist of participants with BM at baseline. All participants will receive Trastuzumab Deruxtecan (T-DXd) intravenously, 5.4mg/kg, every 3 weeks (21-day cycle) until Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) defined radiological progression outside central nervous system, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation is met.