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Recruiting 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

Conditions: Breast Neoplasms

Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: No
Enrollment: 3250
Sponsor: Novartis Pharmaceuticals

Location: Novartis Investigative Site Wiener Neustadt Lower Austria

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 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06830720). StuddyBuddy aggregates publicly available trial information.