PROVIDENCE - 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
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…
Conditions studied
Breast Neoplasms, Breast Cancer, Neoplasm Metastasis
About this study
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).
Primary outcomes
- Real-world Time To Next Treatment (rwTTNT1) (From first dose of T-DXd until initiation of subsequent therapy or death of any cause, whichever came first, assessed up to 60 months)
Eligibility information
Study locations
- Research Site, Amberg, 92224 Germany
- Research Site, Ansbach, 91522 Germany
- Research Site, Apolda, 99510 Germany
- Research Site, Aschaffenburg, 63739 Germany
- Research Site, Augsburg, 86150 Germany
- Research Site, Augsburg, 86156 Germany
- Research Site, Bad Reichenhall, 83435 Germany
- Research Site, Baden-Baden, 76532 Germany
- Research Site, Balingen, 72336 Germany
- Research Site, Bamberg, 96049 Germany
Showing 10 of 109 reported sites. See the official listing for all locations.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-16.