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)
18 Years - 130 Years
Endpoint Classification: -
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Verified 01 Nov 2023 by AstraZeneca
No locations available
|Experimental: Trastuzumab Deruxtecan|
Participants with or without BM at baseline will receive intravenous (IV) T-DXd, 5.4 mg/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.
Drug: Trastuzumab Deruxtecan
Participants will receive T-DXd administered using an IV bag containing 5% (w/v) dextrose injection infusion solution.
Other Name: fam-trastuzumab deruxtecan-nxki