Study Description
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. This non-interventional study aims to provide information on real-world effectiveness, safety and tolerability, management of adverse events, QoL and patient compliance of patients with HR+/HER2- early breast cancer at high risk of recurrence treated with ribociclib in combination with an non-steroidal aromatase inhibitor (NSAI) ± luteinizing hormone-releasing hormone (LHRH) with curative intent according to the German summary of product characteristics.
In order to put the results of patients treated with ribociclib into perspective, socio-economic data, data on QoL and patient compliance will also be collected from patients treated with abemaciclib + endocrine therapy (ET) ± LHRH as described in the respective local summary of product characteristics.
To understand reasons for treatment decision, and to analyze the clinical adoption of ribociclib + NSAI ± LHRH after EU approval over time, baseline data will be collected from cohorts of ribociclib + NSAI ± LHRH, abemaciclib + ET ± LHRH, and additionally from patients treated with ET monotherapy ± LHRH and analyzed cross-sectionally.
The study is planned to be rolled out into a broad set of German and optionally Austrian and Swiss breast centers and gynecological practices to describe clinical routine in a representative subset of the local healthcare eco-system. It will gather insights into the potential benefits and risks associated with ribociclib + NSAI ± LHRH in the adjuvant treatment of HR+/HER2- eBC patients at high risk of recurrence. This knowledge will inform about clinical decision-making and contribute to improved patient outcomes in routine practice.
Interventions
abemaciclib + ET ± LHRH
ET mono ± LHRH
ribociclib + NSAI ± LHRH
Eligibility Criteria
Inclusion Criteria:
* Histological diagnosis of HR+/HER2- early breast cancer with curative intent
* Patients must have an indication for a treatment with ribociclib + NSAI ± LHRH as described in the current SmPC/"Fachinformation" of ribociclib (to be included into the cohorts of ribociclib + NSAI ± 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 + NSAI ± 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 + NSAI ± LHRH cohort: date of therapy start; for abemaciclib + ET ± LHRH cohort: date of therapy start; for ET mono ± LHRH cohort: 4 weeks after therapy start or 4 weeks after last non-endocrine based therapy, whichever is last.
* ≥18 years of age
* Written informed consent
Exclusion Criteria:
* Patient is currently under active treatment in any investigational trial or simultaneously participating in another Novartis-sponsored non-interventional study with ribociclib
* For ribociclib + NSAI ± LHRH cohort: ET pre-treatment is longer than 12 months, according to the current SmPC/"Fachinformation" of ribociclib; for abemaciclib + ET ± LHRH cohort: ET pre-treatment is longer than 12 weeks, according to the current SmPC/"Fachinformation" of abemaciclib
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Balingen,72336,Germany
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Fuerstenwalde,15517,Germany
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Troisdorf,Nordrhein Westfalen,53840,Germany
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Dresden,01127,Germany
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Muehlhausen,99974,Germany
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Marburg,Hessen,35037,Germany
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Berlin,10715,Germany
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Halle,06110,Germany
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Ravensburg,Baden Wuerttemberg,88212,Germany
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Salzwedel,Sachsen,29410,Germany
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Dresden,01307,Germany
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Neustadt In Sachsen,01844,Germany
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Hildesheim,Lower Saxony,31134,Germany
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Berlin,13156,Germany
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Winnenden,Baden Wuerttemberg,71364,Germany
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Hamburg,21073,Germany
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Scheibenberg,Sachsen,09481,Germany
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Ehrenfriedersdorf,09427,Germany
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Twistringen,Lower Saxony,27239,Germany
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Oldenburg,26121,Germany
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Biberach,88400,Germany
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Donauwoerth,Bayern,86609,Germany
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Hamburg,22457,Germany
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Zittau,Sachsen,02763,Germany
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Erfurt,99085,Germany
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Westerstede,Niedersachsen,26655,Germany
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Plauen Kauschwitz,08525,Germany
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Bonn,53123,Germany
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Wuerzburg,Bayern,97070,Germany
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Krefeld,47805,Germany
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Augsburg,86150,Germany
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Essen,45136,Germany
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Wolfenbuettel,Niedersachsen,38304,Germany
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Rotenburg,27356,Germany
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Brandenburg,14770,Germany
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Bad Nauheim,Hessen,61231,Germany
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Leipzig,04103,Germany
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Bad Langensalza,99947,Germany
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Essen,45147,Germany
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Wunstorf,Niedersachsen,31515,Germany
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Werdau,08412,Germany
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Bremen,28209,Germany
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Marktredwitz,95615,Germany
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Langen,Hessen,63225,Germany
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