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).
Eligible participants will be those patients with documented HER2-positive, HER2-low or HER2-ultralow unresectable or metastatic BC receiving T-DXd treatment in line with the applicable summary of product characteristics (SmPC) within routine clinical practice. All diagnostic and treatment procedures including visit frequency are at the discretion of the treating physician and not defined by the protocol. T-DXd treatment is considered as a selection criteria. Patients will be informed about use of digital healthcare application (DiGA). Approximately 800 eligible participants will be enrolled which includes 400 patients in the HER2-positive cohort and 400 patients in the HER2-low/ HER2-ultralow cohort.
Study Type
OBSERVATIONAL
Enrollment
800
Research Site
Amberg, Germany
RECRUITINGResearch Site
Ansbach, Germany
RECRUITINGResearch Site
Apolda, Germany
RECRUITINGResearch Site
Aschaffenburg, Germany
Real-world Time To Next Treatment (rwTTNT1)
rwTTNT1 is defined as the time from T-DXd initiation to initiation of subsequent therapy
Time frame: From first dose of T-DXd until initiation of subsequent therapy or death of any cause, whichever came first, assessed up to 60 months
Change in HRQoL based on FACT-B questionnaire at 6 months after baseline
To evaluate patient-reported outcomes (PROs)/ health-related quality of life (HRQoL) based on FACT-B questionnaire at 6 months after baseline. The Functional Assessment of Cancer Therapy - Breast (FACT-B) is a 37-item instrument designed to measure five domains of HRQoL in breast cancer patients: Physical, social, emotional, functional well-being as well as a breast-cancer subscale (BCS). FACT-B will be collected electronically at time points synchronized with clinic visits during the study.
Time frame: 6 months
Change in HRQoL based on FACT-G questionnaire at 6 months after baseline
To evaluate patient-reported outcomes (PROs)/ health-related quality of life (HRQoL) based on FACT-G questionnaire at 6 months after baseline. The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire designed to measure four domains of HRQoL in cancer patients: Physical, social, emotional, and functional well-being. FACT-G will be collected electronically at time points synchronized with clinic visits during the study.
Time frame: 6 months
AstraZeneca Clinical Study Information Center
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Research Site
Augsburg, Germany
RECRUITINGResearch Site
Augsburg, Germany
RECRUITINGResearch Site
Bad Reichenhall, Germany
RECRUITINGResearch Site
Baden-Baden, Germany
RECRUITINGResearch Site
Balingen, Germany
RECRUITINGResearch Site
Bamberg, Germany
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