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
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 may participate in this NIS.
Cohort
Prospective
Not listed
Real-world Time To Next Treatment (rwTTNT1)
rwTTNT1 is defined as the time from T-DXd initiation to initiation of subsequent therapy
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.
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.
Change in HRQoL based on FACT-B questionnaire compared to baseline over time
Defined as changes in FACT-B (total score and subscale domains) at different timepoints compared to 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).
Change in HRQoL based on EQ-5D questionnaire compared to baseline over time
Defined as changes in EQ-5D (subscale domains and VAS) at different timepoints compared to baseline. EQ-5D is a standardized instrument for use as a measure of patient-reported health outcomes (Euro-QoL). The 5 health-state dimensions in the EQ-5D-5L include: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 5-point scale from 1 (no problem) to 5 (unable to/extreme problems). The EQ-5D-5L also includes a graded (0 to 100) vertical visual analog scale (EQ VAS) on which the participant rates his or her general state of health at the time of the assessment.
Real-world Overall Response Rate (rwORR)
rwORR is defined as percentage of patients having complete response or partial response as best response as determined by the investigator
Real-world Progression-free Survival (rwPFS)
rwPFS is defined as time from T-DXd initiation to the date of the first source evidence for progression referenced by the clinician (e. g., radiology/ pathology report date) or the date of clinician note when no other corresponding evidence sources were documented) or death, whichever occurs first
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AstraZeneca
Lead sponsor
Daiichi Sankyo
Collaborator
