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
Condition(s) studied
Study 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
Primary outcome measure(s)
- 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
rwTTNT1 is defined as the time from T-DXd initiation to initiation of subsequent therapy
Trial sites (109)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Amberg | Germany | Withdrawn |
| Research Site | Ansbach | Germany | Withdrawn |
| Research Site | Apolda | Germany | Recruiting |
| Research Site | Aschaffenburg | Germany | Recruiting |
| Research Site | Augsburg | Germany | Recruiting |
| Research Site | Augsburg | Germany | Recruiting |
| Research Site | Bad Reichenhall | Germany | Recruiting |
| Research Site | Baden-Baden | Germany | Recruiting |
| Research Site | Balingen | Germany | Recruiting |
| Research Site | Bamberg | Germany | Recruiting |
| Research Site | Berlin | Germany | Recruiting |
| Research Site | Berlin | Germany | Recruiting |
| Research Site | Berlin | Germany | Recruiting |
| Research Site | Berlin | Germany | Recruiting |
| Research Site | Berlin | Germany | Recruiting |
| Research Site | Bielefeld | Germany | Recruiting |
| Research Site | Bonn | Germany | Recruiting |
| Research Site | Brandenburg an der Havel | Germany | Recruiting |
| Research Site | Braunschweig | Germany | Recruiting |
| Research Site | Bremen | Germany | Recruiting |
| Research Site | Bremerhaven | Germany | Recruiting |
| Research Site | Coburg | Germany | Recruiting |
| Research Site | Dessau | Germany | Recruiting |
| Research Site | Donauwörth | Germany | Recruiting |
| Research Site | Dortmund | Germany | Recruiting |
| Research Site | Dresden | Germany | Recruiting |
| Research Site | Dresden | Germany | Recruiting |
| Research Site | Düsseldorf | Germany | Recruiting |
| Research Site | Eggenfelden | Germany | Recruiting |
| Research Site | Erfurt | Germany | Withdrawn |
| Research Site | Essen | Germany | Recruiting |
| Research Site | Filderstadt - Bonlanden | Germany | Recruiting |
| Research Site | Frankfurt | Germany | Recruiting |
| Research Site | Freudenstadt | Germany | Recruiting |
| Research Site | Fürstenfeldbruck | Germany | Recruiting |
| Research Site | Fürstenwalde | Germany | Recruiting |
| Research Site | Gerlingen | Germany | Recruiting |
| Research Site | Giessen | Germany | Recruiting |
| Research Site | Halle | Germany | Recruiting |
| Research Site | Hamburg | Germany | Recruiting |
+ 69 more sites — see the full list on the official registry below.
More AstraZeneca trials in Germany
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05573893 on ClinicalTrials.gov ↗ ← All trials in Germany