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NCT06311383Completed

A Non-interventional Study for Women With HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer to Evaluate the Real-world Effectiveness of Treatment Algorithms Beginning With Ribociclib + AI/FUL, or With Endocrine Therapy or Chemotherapy as First Line Treatment

A Non-interventional Study for Women With HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer to Evaluate the Real-world Effectiveness of Treatment Algorithms Beginning With Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor/Fulvestrant, or With Endocrine Therapy or Chemotherapy as First Line Treatment

Source: ClinicalTrials.gov · Last updated 27 Jan 2026

Brief summary (registry, in English)

This is a non-interventional observational study conducted in Germany to evaluate the real-world effectiveness, tolerability, safety, and quality of life in patients with locally advanced/metastatic HR+/HER2- breast cancer treated with one of the following 1st line treatments: Ribociclib + AI/FUL, or endocrine monotherapy, or chemotherapy

Status (registry)
Completed
Study type
Observational
Enrollment
2610 (actual)
First submitted
29 Dec 2023
Start date
9 Oct 2017
Primary completion date
10 Mar 2025
Lead sponsor
Novartis Pharmaceuticals
NCT number
NCT06311383

What you commit to

  • Study type: Observational
  • Participants enrolled: 2610
  • From 9 Oct 2017 to the primary completion date, 10 Mar 2025
  • 195 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Patients unable to provide written informed consent
  • Contra-indication according to the respective current German SmPC ("Summary of product characteristics"), as judged by the treating physician
  • The patient is currently under active treatment in an investigational study

Who the study is looking for

  • Patients with a histological diagnosis of locally advanced/metastatic HR+/HER2- breast cancer. Histological diagnosis does not necessarily origin from metastasis, but must reflect the most recent disease status
  • No prior systemic treatment for locally advanced/metastatic disease in the palliative setting
  • The treating physician has made the decision to treat the patient
  • with ribociclib in combination with an aromatase inhibitor or fulvestrant as initial treatment in first line, or
  • endocrine therapy as initial treatment in first line (e.g. letrozole, anastrozole, fulvestrant), or
  • chemotherapy as initial treatment in first line (e.g. taxanes, capecitabine, with or without bevacizumab)
  • Written informed consent of the patient
  • Patient who initiated treatment for first line no longer than 4 weeks (28 days) prior to written informed consent for this study
  • Planned treatment is in line with the respective current German SmPC ("Summary of product characteristics")
  • Patient is ≥18 years

Age in the registry: 18 years to 100 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (195)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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AltöttingGermanyUnknown status
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AmbergGermanyUnknown status
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AnsbachGermanyUnknown status
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ApoldaGermanyUnknown status
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ArnsbergGermanyUnknown status
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AschaffenburgGermanyUnknown status
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AugsburgGermanyUnknown status
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Baden-BadenGermanyUnknown status
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Bad HomburgGermanyUnknown status
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Bad LiebenwerdaGermanyUnknown status
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Bad NauheimGermanyUnknown status
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BambergGermanyUnknown status
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BayreuthGermanyUnknown status
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Bergisch GladbachGermanyUnknown status
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BerlinGermanyUnknown status
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BielefeldGermanyUnknown status
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BöblingenGermanyUnknown status
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BochumGermanyUnknown status
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BonnGermanyUnknown status
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BottropGermanyUnknown status
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BrandenburgGermanyUnknown status
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Brandenburg an der HavelGermanyUnknown status
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BraunschweigGermanyUnknown status
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BremenGermanyUnknown status
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BremerhavenGermanyUnknown status
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BuchholzGermanyUnknown status
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CelleGermanyUnknown status
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ChemnitzGermanyUnknown status
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CologneGermanyUnknown status
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CottbusGermanyUnknown status
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DammeGermanyUnknown status
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DarmstadtGermanyUnknown status
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DessauGermanyUnknown status
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Doberlug-KirchhainGermanyUnknown status
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DonauwörthGermanyUnknown status
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DortmundGermanyUnknown status
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DresdenGermanyUnknown status
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DüsseldorfGermanyUnknown status
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EbersbergGermanyUnknown status
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EggenfeldenGermanyUnknown status
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EisenachGermanyUnknown status
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Erbach im OdenwaldGermanyUnknown status
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ErfurtGermanyUnknown status
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ErlangenGermanyUnknown status
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EssenGermanyUnknown status
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Esslingen am NeckarGermanyUnknown status
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EutinGermanyUnknown status
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FlensburgGermanyUnknown status
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Frankfurt am MainGermanyUnknown status
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Freiburg im BreisgauGermanyUnknown status
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FreudenstadtGermanyUnknown status
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FriedbergGermanyUnknown status
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FriedrichshafenGermanyUnknown status
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FürstenwaldeGermanyUnknown status
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GelsenkirchenGermanyUnknown status
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GeorgsmarienhütteGermanyUnknown status
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GeraGermanyUnknown status
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GochGermanyUnknown status
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GoslarGermanyUnknown status
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GöttingenGermanyUnknown status
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GreifswaldGermanyUnknown status
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GummersbachGermanyUnknown status
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HagenGermanyUnknown status
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HalberstadtGermanyUnknown status
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HalleGermanyUnknown status
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HamburgGermanyUnknown status
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HamelinGermanyUnknown status
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HanauGermanyUnknown status
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HanoverGermanyUnknown status
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HeidenheimGermanyUnknown status
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HerdeckeGermanyUnknown status
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HerneGermanyUnknown status
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HildenGermanyUnknown status
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HildesheimGermanyUnknown status
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HofGermanyUnknown status
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HomburgGermanyUnknown status
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IlsedeGermanyUnknown status
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JenaGermanyUnknown status
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KaiserslauternGermanyUnknown status
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KarlsruheGermanyUnknown status
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KasselGermanyUnknown status
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Kempten (Allgäu)GermanyUnknown status
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KielGermanyUnknown status
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KoblenzGermanyUnknown status
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KrefeldGermanyUnknown status
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KronachGermanyUnknown status
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KrumbachGermanyUnknown status
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KulmbachGermanyUnknown status
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LandshutGermanyUnknown status
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LangenGermanyUnknown status
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LebachGermanyUnknown status
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LeipzigGermanyUnknown status
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LemgoGermanyUnknown status
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LichGermanyUnknown status
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LingenGermanyUnknown status
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LoerrachGermanyUnknown status
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Lohsa-WeisskollmGermanyUnknown status
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LübeckGermanyUnknown status
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LudwigsfeldeGermanyUnknown status
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MagdeburgGermanyUnknown status
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MainzGermanyUnknown status
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MannheimGermanyUnknown status
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MarburgGermanyUnknown status
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MarktredwitzGermanyUnknown status
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MayenGermanyUnknown status
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MeiningenGermanyUnknown status
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MemmingenGermanyUnknown status
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MindenGermanyUnknown status
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MoersGermanyUnknown status
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MönchengladbachGermanyUnknown status
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MühlhausenGermanyUnknown status
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MunichGermanyUnknown status
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MünsterGermanyUnknown status
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MutlangenGermanyUnknown status
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NaunhofGermanyUnknown status
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NeubrandenburgGermanyUnknown status
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NeuruppinGermanyUnknown status
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NeussGermanyUnknown status
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Neustadt an der WeinstraßeGermanyUnknown status
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Neustadt in SachsenGermanyUnknown status
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NordhausenGermanyUnknown status
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NurembergGermanyUnknown status
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NürtingenGermanyUnknown status
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OffenbachGermanyUnknown status
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OffenburgGermanyUnknown status
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OldenburgGermanyUnknown status
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OlpeGermanyUnknown status
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OsnabrückGermanyUnknown status
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OstfildernGermanyUnknown status
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PaderbornGermanyUnknown status
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PassauGermanyUnknown status
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PforzheimGermanyUnknown status
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PirnaGermanyUnknown status
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PlauenGermanyUnknown status
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PotsdamGermanyUnknown status
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QuedlinburgGermanyUnknown status
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RavensburgGermanyUnknown status
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RegensburgGermanyUnknown status
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RemscheidGermanyUnknown status
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ReutlingenGermanyUnknown status
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RheineGermanyUnknown status
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RodewischGermanyUnknown status
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RodgauGermanyUnknown status
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RosenheimGermanyUnknown status
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RostockGermanyUnknown status
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Rotenburg (Wümme)GermanyUnknown status
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RottweilGermanyUnknown status
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Rüsselsheim am MainGermanyUnknown status
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SaarbrückenGermanyUnknown status
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SaarlouisGermanyUnknown status
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SalzgitterGermanyUnknown status
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ScheibenbergGermanyUnknown status
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SchkeuditzGermanyUnknown status
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SchorndorfGermanyUnknown status
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Schwäbisch HallGermanyUnknown status
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SchweinfurtGermanyUnknown status
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SchwerinGermanyUnknown status
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SchwerteGermanyUnknown status
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SiegenGermanyUnknown status
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SigmaringenGermanyUnknown status
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SimmernGermanyUnknown status
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SoestGermanyUnknown status
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SprembergGermanyUnknown status
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StadeGermanyUnknown status
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StendalGermanyUnknown status
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StolbergGermanyUnknown status
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StralsundGermanyUnknown status
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StraubingGermanyUnknown status
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StuttgartGermanyUnknown status
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SuhlGermanyUnknown status
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TorgauGermanyUnknown status
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TrierGermanyUnknown status
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TroisdorfGermanyUnknown status
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TübingenGermanyUnknown status
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TwistringenGermanyUnknown status
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UlmGermanyUnknown status
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VechtaGermanyUnknown status
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VelbertGermanyUnknown status
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VölklingenGermanyUnknown status
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WeidenGermanyUnknown status
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WeinheimGermanyUnknown status
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WeselGermanyUnknown status
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WesterstedeGermanyUnknown status
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WetzlarGermanyUnknown status
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WiesbadenGermanyUnknown status
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WilhelmshavenGermanyUnknown status
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WinnendenGermanyUnknown status
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WittenGermanyUnknown status
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WolfenbüttelGermanyUnknown status
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WolfsburgGermanyUnknown status
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WormsGermanyUnknown status
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WürselenGermanyUnknown status
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WürzburgGermanyUnknown status
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ZittauGermanyUnknown status
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ZxickauGermanyUnknown status

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