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Brief Title: PROVIDENCE - Prospective Non-interventional Study (NIS) to Examine Patient-reported Outcomes and Real-world Clinical Data in Patients With HER2-positive or HER2-low Unresectable or Metastatic Breast Cancer Treated With Trastuzumab Deruxtecan
Official Title: Prospective Non-interventional Study (NIS) to Examine Patient-reported Outcomes and Real-world Clinical Data in Patients With HER2-positive or HER2-low Unresectable or Metastatic Breast Cancer Treated With Trastuzumab Deruxtecan
Study ID: NCT05573893
Brief Summary: 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 unresectable or metastatic breast cancer (BC) and in patients with documented HER2-low unresectable or metastatic 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).
Detailed Description: Eligible participants will be those patients with documented HER2-positive unresectable or metastatic BC receiving T-DXd for 2L treatment or patients with documented HER2-low 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 cohort.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Research Site, Amberg, , Germany
Research Site, Ansbach, , Germany
Research Site, Aschaffenburg, , Germany
Research Site, Augsburg, , Germany
Research Site, Bad Reichenhall, , Germany
Research Site, Baden-Baden, , Germany
Research Site, Beremerhaven, , Germany
Research Site, Berlin, , Germany
Research Site, Bonn, , Germany
Research Site, Brandenburg an der Havel, , Germany
Research Site, Braunschweig, , Germany
Research Site, Bremen, , Germany
Research Site, Donauwoerth, , Germany
Research Site, Dortmund, , Germany
Research Site, Eggenfelden, , Germany
Research Site, Erfurt, , Germany
Research Site, Freudenstadt, , Germany
Research Site, Fuerstenwalde, , Germany
Research Site, Gerlingen, , Germany
Research Site, Giessen, , Germany
Research Site, Hamburg, , Germany
Research Site, Hannover, , Germany
Research Site, Hannover, , Germany
Research Site, Heidenheim, , Germany
Research Site, Heilbronn, , Germany
Research Site, Hildesheim, , Germany
Research Site, Homburg/Saar, , Germany
Research Site, Karlsruhe, , Germany
Research Site, Kassel, , Germany
Research Site, Kiel, , Germany
Research Site, Kulmbach, , Germany
Research Site, Landshut, , Germany
Research Site, Leer, , Germany
Research Site, Leipzig, , Germany
Research Site, Loerrach, , Germany
Research Site, Lüneburg, , Germany
Research Site, Magdeburg, , Germany
Research Site, Mainz, , Germany
Research Site, Moenchengladbach, , Germany
Research Site, Mutlangen, , Germany
Research Site, Mühlhausen, , Germany
Research Site, Neumarkt, , Germany
Research Site, Oranienburg, , Germany
Research Site, Potsdam, , Germany
Research Site, Regensburg, , Germany
Research Site, Rosenheim, , Germany
Research Site, Rotenburg (Wuemme), , Germany
Research Site, Singen, , Germany
Research Site, Solingen, , Germany
Research Site, Stuttgart, , Germany
Research Site, Torgau, , Germany
Research Site, Troisdorf, , Germany
Research Site, Ulm, , Germany
Research Site, Weinheim, , Germany
Research Site, Westerstede, , Germany
Research Site, Wiesbaden, , Germany
Research Site, Winnenden, , Germany
Research Site, Zittau, , Germany