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

Overview

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 aromatase inhibitor (AI) ± luteinizing hormone-releasing hormone (LHRH) with curative intent according to the current effective local 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 current effective local summary of product characteristics.

To understand reasons for treatment decision, and to analyze the clinical adoption of ribociclib + AI ± LHRH after EU approval over time, baseline data will be collected from cohorts of ribociclib + AI ± 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 Austrian 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 + AI ± 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

• Drug ribociclib + AI ± LHRH
  ribociclib in combination with an aromatase inhibitor ± LHRH as described in the current effective summary of product characteristics. This is an observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.
• Drug abemaciclib + ET ± LHRH
  abemaciclib in combination with an endocrine therapy ± LHRH as described in the current effective summary of product characteristics. This is an observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.
• Drug ET mono ± LHRH
  endocrine monotherapy ± LHRH. This is an observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.

Primary outcome measures

• Invasive disease-free survival (iDFS) for adjuvant therapy with ribociclib + AI ± LHRH in participants with HR+/HER2- eBC at high risk of recurrence [Time frame: 36 months]

Secondary outcome measures (12)

• Number of participants per Baseline parameters [Time frame: baseline]
• Reasons for treatment decision by treating physician [Time frame: baseline]
• Patients' individual perception of risk of recurrence and treatment decision [Time frame: baseline]
• Invasive disease-free survival (iDFS) (ribociclib cohort) [Time frame: 12 and 24 months]
• Invasive breast cancer-free survival (iBCFS) (ribociclib cohort) [Time frame: 12, 24 and 36 months]
• Recurrence-free survival (RFS) (ribociclib cohort) [Time frame: 12, 24 and 36 months]
• Distant disease-free survival (DDFS) (ribociclib cohort) [Time frame: 12, 24 and 36 months]
• Incidence and severity of adverse events (ribociclib cohort) [Time frame: up to 36 months]
• Dose modification rates (ribociclib cohort) [Time frame: up to 36 months]
• Treatment interruption rates (ribociclib cohort) [Time frame: up to 36 months]
• Discontinuation rates (ribociclib cohort) [Time frame: up to 36 months]
• Time to discontinuation (TTD) (ribociclib cohort) [Time frame: up to 36 months]

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 + 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

Exclusion criteria

\- Patient is simultaneously participating in any investigational trial or simultaneously participating in another Novartis-sponsored non-interventional study with ribociclib.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Germany · 275 centers

• Novartis Investigative Site — Baden-Baden
• Novartis Investigative Site — Filderstadt
• Novartis Investigative Site — Freudenstadt
• Novartis Investigative Site — Heidelberg
• Novartis Investigative Site — Heidenheim
• Novartis Investigative Site — Konstanz
• Novartis Investigative Site — Mannheim
• Novartis Investigative Site — Mannheim
• … and 267 more centers

Austria · 12 centers

• Novartis Investigative Site — Wiener Neustadt
• Novartis Investigative Site — Innsbruck
• Novartis Investigative Site — Linz
• Novartis Investigative Site — Graz
• Novartis Investigative Site — Klagenfurt
• Novartis Investigative Site — Leoben
• Novartis Investigative Site — Schwaz
• Novartis Investigative Site — Steyr
• … and 4 more centers

Identifiers

NCT: NCT06830720 · CLEE011O1DE01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗