This is a prospective non-interventional, multicenter study observing patient reported outcomes as well as real-world efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients with documented Human epidermal growth factor receptor 2 (HER2)-positive, HER2-low or HER2-ultralow unresectable or metastatic breast cancer (BC) receiving T-DXd in line with the applicable summary of product characteristics (SmPC) within routine clinical practice in Germany. In addition, patients will be informed about use of digital healthcare application (DiGA).
Adults ≥ 18 years old
is unresectable or metastatic
has confirmed HER2+, HER2-low or HER2-ultralow tumor status by local pathology
was previously treated with one or more anti-HER2 directed therapy if the tumor is HER2+ OR
Start of T-DXd treatment for more than 30 days before enrolment (eCRF registration date)
Known hypersensitivity to T-DXd or any of the excipients of the drug
Pregnancy or breast feeding
Current or planned participation in an interventional clinical trial
AstraZeneca
Lead sponsor
Daiichi Sankyo
Collaborator