Clinical trial NCT06830720: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Neoplasms
Keywords: Non-interventional study
NIS
breast cancer
early breast cancer
HR+
HER-
ribociclib
real world evidence
adjuvant therapy
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2025-02-17
Enrollment: 3250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult female and male patients with an indication for adjuvant treatment with ribociclib + NSAI ± LHRH (or abemaciclib + ET ± LHRH for the abemaciclib cohort) in HR+/HER2- eBC at high risk of recurrence as described in the German summary of product characteristics enrolled from specialized centers, hospitals and outpatient centers.

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Invasive disease-free survival (iDFS) for adjuvant therapy with ribociclib + NSAI ± LHRH in participants with HR+/HER2- eBC at high risk of recurrence
timeFrame: 36 months
Secondary outcomes:
measure: Number of participants per Baseline parameters
timeFrame: baseline
measure: Reasons for treatment decision by treating physician
timeFrame: baseline
measure: Invasive disease-free survival (iDFS) (ribociclib cohort)
timeFrame: 12 and 24 months
measure: Invasive breast cancer-free survival (iBCFS) (ribociclib cohort)
timeFrame: 12, 24 and 36 months
measure: Recurrence-free survival (RFS) (ribociclib cohort)
timeFrame: 12, 24 and 36 months
measure: Distant disease-free survival (DDFS) (ribociclib cohort)
timeFrame: 12, 24 and 36 months
measure: Incidence and severity of adverse events (ribociclib cohort)
timeFrame: up to 36 months
measure: Dose modification rates (ribociclib cohort)
timeFrame: up to 36 months
measure: Treatment interruption rates (ribociclib cohort)
timeFrame: up to 36 months
measure: Discontinuation rates (ribociclib cohort)
timeFrame: up to 36 months
measure: Time to discontinuation (TTD) (ribociclib cohort)
timeFrame: up to 36 months
measure: Quality of life by EORTC QLQ-C30 (ribociclib and abemaciclib cohorts)
timeFrame: up to 39 months
measure: Quality of life by EORTC QLQ-BR42 (ribociclib and abemaciclib cohorts)
timeFrame: up to 39 months
measure: Quality of life by HADS D (ribociclib and abemaciclib cohorts)
timeFrame: up to 39 months
measure: Participant compliance as assessed by the Medication Adherence Report Scale (MARS-5) (ribociclib and abemaciclib cohorts)
timeFrame: up to 36 months
measure: Participant compliance as assessed by a physician adherence rating (ribociclib cohort)
timeFrame: up to 36 months
measure: Participant compliance as assessed by neutrophil count (ribociclib cohort)
timeFrame: up to 36 months
measure: Impact of type and change of treatment facility and health care professionals involved in treatment management on participant compliance assessed by MARS-5 (ribociclib cohort)
timeFrame: up to 36 months
measure: Impact of digital health solutions applied in clinical routine on participant compliance assessed by MARS-5 (ribociclib cohort)
timeFrame: up to 36 months
measure: Socio-economic status of participants measured by WPAI-GH (ribociclib and abemaciclib cohorts)
timeFrame: up to 39 months
measure: Number of participants per reason for treatment discontinuation (ribociclib and abemaciclib cohorts)
timeFrame: up to 39 months
measure: Type of subsequent anti-neoplastic therapies (ribociclib and abemaciclib cohorts)
timeFrame: up to 39 months
measure: Time to subsequent anti-neoplastic therapy (ribociclib and abemaciclib cohorts)
timeFrame: up to 39 months
measure: Impact of an active participation of the participant in the treatment decision on subsequent participant compliance measured by MARS-5 (ribociclib cohort)
timeFrame: up to 36 months
measure: Impact of participants' fear of cancer recurrence on participant compliance measured by MARS-5 (ribociclib cohort)
timeFrame: up to 36 months
measure: Participants' expectations regarding therapy, side effects and management (ribociclib and abemaciclib cohorts)
timeFrame: baseline
measure: Participants' treatment satisfaction (ribociclib and abemaciclib cohorts)
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Filderstadt
country: Germany
facility: Novartis Investigative Site
state: Baden Wuerttemberg
city: Freudenstadt
country: Germany
facility: Novartis Investigative Site
state: Baden Wuerttemberg
city: Heidenheim
country: Germany
facility: Novartis Investigative Site
state: Baden Wuerttemberg
city: Mannheim
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state: Baden Wuerttemberg
city: Nuertingen
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city: Ravensburg
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city: Reutlingen
country: Germany
facility: Novartis Investigative Site
state: Baden Wuerttemberg
city: Schwaebisch
country: Germany
facility: Novartis Investigative Site
state: Baden Wuerttemberg
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facility: Novartis Investigative Site
state: Baden Wuerttemberg
city: Herrsching
country: Germany
facility: Novartis Investigative Site
state: Bavaria
city: Munich
country: Germany
facility: Novartis Investigative Site
state: Bavaria
city: Augsburg
country: Germany
facility: Novartis Investigative Site
state: Bayern
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facility: Novartis Investigative Site
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country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Muenchen
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Traunstein
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Wuerzburg
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Cottbus
country: Germany
facility: Novartis Investigative Site
state: Brandenburg
city: Bremerhaven
country: Germany
facility: Novartis Investigative Site
state: Bremen
city: Bad Nauheim
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Frankfurt am Main
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Langen
country: Germany
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state: Hessen
city: Marburg
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Twistringen
country: Germany
facility: Novartis Investigative Site
state: Lower Saxony
city: Rostock
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state: Mecklenburg Vorpommern
city: Braunschweig
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Georgsmarienhuette
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Goettingen
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Hildesheim
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Ilsede
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Osnabrueck
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facility: Novartis Investigative Site
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city: Westerstede
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facility: Novartis Investigative Site
state: Niedersachsen
city: Wolfenbuettel
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facility: Novartis Investigative Site
state: Niedersachsen
city: Wunstorf
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Bergisch Gladbach
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city: Bielefeld
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country: Germany
facility: Novartis Investigative Site
state: Nordrhein Westfalen
city: Bonn
country: Germany
facility: Novartis Investigative Site
state: Nordrhein Westfalen
city: Dortmund
country: Germany
facility: Novartis Investigative Site
state: Nordrhein Westfalen
city: Koeln
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facility: Novartis Investigative Site
state: Nordrhein Westfalen
city: Troisdorf
country: Germany
facility: Novartis Investigative Site
state: Nordrhein Westfalen
city: Bielefeld
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facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Remscheid
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facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Velbert
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facility: Novartis Investigative Site
state: North Rhine-Westphalia
city: Lebach
country: Germany
facility: Novartis Investigative Site
state: Saarland
city: Stendal
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facility: Novartis Investigative Site
state: Sachsen Anhalt
city: Halle Saale
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facility: Novartis Investigative Site
state: Sachsen-Anhalt
city: Halle Saale
country: Germany
facility: Novartis Investigative Site
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
state: Sachsen-Anhalt
city: Magdeburg
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facility: Novartis Investigative Site
state: Sachsen-Anhalt
city: Dresden
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facility: Novartis Investigative Site
state: Sachsen
city: Leipzig
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facility: Novartis Investigative Site
state: Sachsen
city: Salzwedel
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Scheibenberg
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Schkeuditz
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Zittau
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facility: Novartis Investigative Site
state: Sachsen
city: Luebeck
country: Germany
facility: Novartis Investigative Site
state: Schleswig-Holstein
city: Aachen
country: Germany
facility: Novartis Investigative Site
city: Apolda
country: Germany
facility: Novartis Investigative Site
city: Augsburg
country: Germany
facility: Novartis Investigative Site
city: Bad Langensalza
country: Germany
facility: Novartis Investigative Site
city: Bad Mergentheim
country: Germany
facility: Novartis Investigative Site
city: Balingen
country: Germany
facility: Novartis Investigative Site
city: Bamberg
country: Germany
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country: Germany
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country: Germany
facility: Novartis Investigative Site
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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city: Dillingen A D Donau
country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
facility: Novartis Investigative Site
city: Ehrenfriedersdorf
country: Germany
facility: Novartis Investigative Site
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country: Germany
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city: Erfurt
country: Germany
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city: Eschweiler
country: Germany
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city: Essen
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Freiburg
country: Germany
facility: Novartis Investigative Site
city: Fuerstenwalde
country: Germany
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city: Gera
country: Germany
facility: Novartis Investigative Site
city: Gerlingen
country: Germany
facility: Novartis Investigative Site
city: Goslar
country: Germany
facility: Novartis Investigative Site
city: Guenzburg
country: Germany
facility: Novartis Investigative Site
city: Gummersbach
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Hennigsdorf
country: Germany
facility: Novartis Investigative Site
city: Jena
country: Germany
facility: Novartis Investigative Site
city: Jena
country: Germany
facility: Novartis Investigative Site
city: Karlsruhe
country: Germany
facility: Novartis Investigative Site
city: Kempten
country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Krefeld
country: Germany
facility: Novartis Investigative Site
city: Kulmbach
country: Germany
facility: Novartis Investigative Site
city: Loerrach
country: Germany
facility: Novartis Investigative Site
city: Marktredwitz
country: Germany
facility: Novartis Investigative Site
city: Moers
country: Germany
facility: Novartis Investigative Site
city: Muehlhausen
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Naunhof
country: Germany
facility: Novartis Investigative Site
city: Neubrandenburg
country: Germany
facility: Novartis Investigative Site
city: Neuss
country: Germany
facility: Novartis Investigative Site
city: Neustadt In Sachsen
country: Germany
facility: Novartis Investigative Site
city: Nordhausen
country: Germany
facility: Novartis Investigative Site
city: Offenburg
country: Germany
facility: Novartis Investigative Site
city: Oldenburg
country: Germany
facility: Novartis Investigative Site
city: Passau
country: Germany
facility: Novartis Investigative Site
city: Plauen Kauschwitz
country: Germany
facility: Novartis Investigative Site
city: Potsdam
country: Germany
facility: Novartis Investigative Site
city: Prien A Chiemsee
country: Germany
facility: Novartis Investigative Site
city: Rostock
country: Germany
facility: Novartis Investigative Site
city: Rotenburg
country: Germany
facility: Novartis Investigative Site
city: Saalfeld Saale
country: Germany
facility: Novartis Investigative Site
city: Schorndorf
country: Germany
facility: Novartis Investigative Site
city: Schweinfurt
country: Germany
facility: Novartis Investigative Site
city: Sigmaringen
country: Germany
facility: Novartis Investigative Site
city: Singen
country: Germany
facility: Novartis Investigative Site
city: Soest
country: Germany
facility: Novartis Investigative Site
city: Stralsund
country: Germany
facility: Novartis Investigative Site
city: Torgau
country: Germany
facility: Novartis Investigative Site
city: Tuebingen
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Waldkirchen
country: Germany
facility: Novartis Investigative Site
city: Waldsassen
country: Germany
facility: Novartis Investigative Site
city: Weiden
country: Germany
facility: Novartis Investigative Site
city: Werdau
country: Germany
facility: Novartis Investigative Site
city: Wesel
country: Germany
facility: Novartis Investigative Site
city: Winse Luhe
country: Germany
facility: Novartis Investigative Site
city: Wuerzburg
country: Germany
facility: Novartis Investigative Site
Study officials:
References: