A Non-interventional Study for Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor fo… (NCT06830720) | Clinical Trial Compass
RecruitingNot Applicable
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
Austria3,250 participantsStarted 2025-02-20
Plain-language 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.
Who can participate
Age range18 Years – 100 Years
SexALL
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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.
What they're measuring
1
Invasive disease-free survival (iDFS) for adjuvant therapy with ribociclib + AI ± LHRH in participants with HR+/HER2- eBC at high risk of recurrence