A Non-interventional Study for Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor for Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer at High Risk of Recurrence to Evaluate Real-world Effectiveness, Safety Profile, Patient Compliance and Quality of Life

Status: Recruiting
Location: See all (224) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY

This non-interventional observational study evaluates the real-world effectiveness and safety profile of ribociclib in combination with an aromatase inhibitor for adjuvant treatment in patients with HR+/HER2- early breast cancer at high risk of recurrence, as well as patient compliance and quality of life.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Histological diagnosis of HR+/HER2- early breast cancer with curative intent

• Patients must have an indication for a treatment with ribociclib + AI ± LHRH as described in the current SmPC/Fachinformation of ribociclib (to be included into the cohorts of ribociclib + AI ± LHRH and ET mono ± LHRH) or abemaciclib + ET ± LHRH as described in the current SmPC/Fachinformation of abemaciclib (to be included into the abemaciclib + ET ± LHRH cohort) in the adjuvant setting

• Before enrollment the treating physician has made the decision in accordance with the patient to treat the patient with either

‣ ribociclib + AI ± LHRH, or

⁃ ET mono ± LHRH, or

⁃ abemaciclib + ET ± LHRH and baseline is no longer than 2 weeks (14 days) prior to written informed consent for this study.

∙ Baseline = for ribociclib + AI ± LHRH cohort: date of therapy start; for abemaciclib + ET ± LHRH cohort: date of therapy start; for ET mono ± LHRH cohort: within 4 weeks after therapy start or within 4 weeks after last non-endocrine based therapy, whichever is last.

• ≥18 years of age

• Written informed consent

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Austria
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Vienna
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Vienna
Germany
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Aachen
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Altötting
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Amberg
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Ansbach
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Apolda
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Augsburg
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Augsburg
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Bad Friedrichshall
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Bad Homburg
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Bad Langensalza
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Bad Mergentheim
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Bad Nauheim
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Bad Reichenhall
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Balingen
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Bamberg
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Bautzen
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Bayreuth
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Bergisch Gladbach
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Biberach
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Bielefeld
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Bielefeld
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Böblingen
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Bochum
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Bochum
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Bonn
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Bonn
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Bonn
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Bonn
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Borna
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Bottrop
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Brandenburg
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Brandenburg
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Braunschweig
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Bremen
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Bremen
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Bremen
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Bremerhaven
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Bremerhaven
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Bruchsal
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Celle
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Chemnitz
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Chemnitz
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Cologne
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Cologne
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Cottbus
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Dachau
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Dessau
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Dillingen A D Donau
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Donauwörth
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Dorfen
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Dortmund
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Dresden
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Dresden
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Dresden
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Düsseldorf
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Düsseldorf
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Düsseldorf
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Düsseldorf
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Ebersberg
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Eggenfelden
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Ehingen
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Ehrenfriedersdorf
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Erfurt
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Erfurt
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Eschweiler
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Essen
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Essen
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Esslingen Am Neckar
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Filderstadt
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Flensburg
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Frankfurt Am Main
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Frankfurt Am Main
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Freiburg Im Breisgau
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Freudenstadt
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Fürstenwalde
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Fürth
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Georgsmarienhütte
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Gera
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Gerlingen
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Goslar
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Göttingen
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Göttingen
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Gummersbach
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Günzburg
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Hagen
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Halle
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Halle
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Hamburg
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Hamburg
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Hamburg
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Hamburg
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Hanover
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Heide
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Heidelberg
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Heidenheim
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Heilbronn
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Hennigsdorf
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Herrsching Am Ammersee
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Hildesheim
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Homburg
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Ilsede
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Jena
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Jena
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Karlsruhe
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Kempten
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Kiel
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Königs Wusterhausen
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Kronach
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Landsberg Am Lech
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Langen
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Lebach
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Leipzig
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Leipzig
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Loerrach
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Lübeck
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Lübeck
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Magdeburg
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Magdeburg
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Mainz
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Mannheim
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Mannheim
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Marburg
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Marburg
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Marktredwitz
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Moers
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Mönchengladbach
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Munich
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Munich
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Munich
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Münster
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Münster
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Mutlangen
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Naunhof
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Neubrandenburg
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Neuss
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Neustadt In Sachsen
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Nuremberg
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Nuremberg
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Nürtingen
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Offenburg
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Oldenburg
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Olpe
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Osnabrück
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Paderborn
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Passau
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Potsdam
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Prien A Chiemsee
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Radebeul
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Ravensburg
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Regensburg
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Remscheid
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Reutlingen
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Rodewisch
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Rosenheim
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Rostock
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Rostock
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Rotenburg (wümme)
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Rüsselsheim Am Main
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Saalfeld
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Saarlouis
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Salzwedel
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Scheibenberg
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Schkeuditz
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Siegen
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Sigmaringen
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Singen
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Soest
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Speyer
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Stendal
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Stralsund
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Stuttgart
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Stuttgart
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Suhl
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Torgau
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Traunstein
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Trier
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Troisdorf
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Tübingen
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Twistringen
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Ulm
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Ulm
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Velbert
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Waldkirchen
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Waldmuenchen
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Waldsassen
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Walsrode
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Weiden
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Weinheim
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Werdau
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Wernigerode
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Wesel
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Westerstede
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Wiesbaden
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Wiesbaden
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Winnenden
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Winse Luhe
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Witten
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Wolfenbüttel
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Worms
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Wunstorf
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Würzburg
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Würzburg
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Zittau
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Backup
Novartis Pharmaceuticals
Time Frame
Start Date: 2025-02-20
Estimated Completion Date: 2030-06-30
Participants
Target number of participants: 3250
Treatments
ribociclib
ribociclib + AI ± LHRH
abemaciclib
abemaciclib + ET ± LHRH
ET mono
ET mono ± LHRH
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov

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