RecruitingNCT05573893

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

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


Sponsor

AstraZeneca

Enrollment

800 participants

Start Date

Sep 12, 2023

Study Type

OBSERVATIONAL

Conditions

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, 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).


Eligibility

Min Age: 18 YearsMax Age: 130 Years

Plain Language Summary

Simplified for easier understanding

This observational study is tracking real-world outcomes for patients with HER2-positive, HER2-low, or HER2-ultralow unresectable or metastatic breast cancer who are being treated with a drug called trastuzumab deruxtecan (T-DXd). The goal is to understand how patients feel during treatment and how well it works in everyday clinical settings. **You may be eligible if...** - You are 18 or older with metastatic or unresectable breast cancer - Your tumor has been confirmed as HER2-positive, HER2-low, or HER2-ultralow - You have previously received appropriate prior therapy based on your tumor type - Your doctor has decided to treat you with trastuzumab deruxtecan as part of your standard care **You may NOT be eligible if...** - You are not receiving trastuzumab deruxtecan as part of your treatment - You have not had prior treatment as required based on your tumor subtype Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(107)

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Amberg, Germany

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Ansbach, Germany

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Apolda, Germany

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Aschaffenburg, Germany

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Augsburg, Germany

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Augsburg, Germany

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Bad Reichenhall, Germany

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Baden-Baden, Germany

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Balingen, Germany

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Bamberg, Germany

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Berlin, Germany

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Berlin, Germany

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Berlin, Germany

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Berlin, Germany

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Berlin, Germany

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Bielefeld, Germany

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Bonn, Germany

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Brandenburg an der Havel, Germany

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Braunschweig, Germany

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Bremen, Germany

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Bremerhaven, Germany

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Coburg, Germany

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Dessau, Germany

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Donauwörth, Germany

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Dortmund, Germany

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Dresden, Germany

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Dresden, Germany

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Düsseldorf, Germany

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Eggenfelden, Germany

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Erfurt, Germany

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Essen, Germany

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Filderstadt - Bonlanden, Germany

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Frankfurt, Germany

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Freudenstadt, Germany

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Fürstenfeldbruck, Germany

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Fürstenwalde, Germany

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Gerlingen, Germany

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Giessen, Germany

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Halle, Germany

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Hamburg, Germany

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Hamburg, Germany

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Hanover, Germany

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Hanover, Germany

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Hansestadt Salzwedel, Germany

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Heidenheim, Germany

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Heilbronn, Germany

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Hildesheim, Germany

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Homburg/Saar, Germany

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Jena, Germany

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Kaiserslautern, Germany

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Karlsruhe, Germany

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Kassel, Germany

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Kassel, Germany

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Kempten, Germany

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Kiel, Germany

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Krefeld, Germany

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Kulmbach, Germany

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Landshut, Germany

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Leer, Germany

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Leipzig, Germany

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Loerrach, Germany

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Lübeck, Germany

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Lüneburg, Germany

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Magdeburg, Germany

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Mainz, Germany

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Marburg, Germany

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Memmingen, Germany

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Mönchengladbach, Germany

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Mutlangen, Germany

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Mühlhausen, Germany

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München, Germany

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München, Germany

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München, Germany

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Neumarkt, Germany

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Neustadt am Rübenberge, Germany

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Nordhausen, Germany

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Nuremberg, Germany

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Oldenburg, Germany

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Oranienburg, Germany

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Potsdam, Germany

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Recklinghausen, Germany

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Regensburg, Germany

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Rosenheim, Germany

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Rotenburg (Wümme), Germany

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Saalfeld, Germany

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Saarbrücken, Germany

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Schwäbisch Hall, Germany

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Siegen, Germany

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Singen, Germany

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Solingen, Germany

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Stade, Germany

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Stuttgart, Germany

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Torgau, Germany

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Troisdorf, Germany

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Ulm, Germany

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Walsrode, Germany

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Weiden, Germany

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Weinheim, Germany

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Weißenfels, Germany

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Westerstede, Germany

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Wiesbaden, Germany

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Winnenden, Germany

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Witten, Germany

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Wolfsburg, Germany

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Wuppertal, Germany

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Würzburg, Germany

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Zittau, Germany

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NCT05573893


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