Study identifier:D9673R00028
ClinicalTrials.gov identifier:NCT05573893
EudraCT identifier:N/A
CTIS identifier:N/A
Prospective non-interventional study (NIS) to examine patient-reported outcomes and real-world clinical data in patients with HER2-positive, HER2-low or HER2-ultralow unresectable or metastatic breast cancer treated with Trastuzumab Deruxtecan
Breast Neoplasms
N/A
No
-
All
800
Observational
18 Years - 130 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 May 2025 by AstraZeneca
AstraZeneca
Daiichi Sankyo
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.
Location
Status
Location
Freudenstadt, Germany, 72250
Status
Recruiting
Location
Neumarkt, Germany, 92318
Status
Recruiting
Location
Donauwoerth, Germany, 86609
Status
Recruiting
Location
Bonn, Germany, 53111
Status
Recruiting
Location
Amberg, Germany, 92224
Status
Recruiting
Location
Loerrach, Germany, 79539
Status
Recruiting
Location
Augsburg, Germany, 86150
Status
Recruiting
Location
Baden-Baden, Germany, 76532
Status
Recruiting
Arms | Assigned Interventions |
---|---|
Cohort 1 Cohort 1 containing patients with documented HER2-positive unresectable or metastatic BC receiving T-DXd treatment in line with the applicable summary of product characteristics (SmPC) within routine clinical practice. | - |
Cohort 2 Cohort 2 containing patients with documented 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. | - |
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