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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

Recruitingn/aAges 18 Years - 100 YearsAllNovartis Pharmaceuticals
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • ribociclib + AI ± LHRH
  • abemaciclib + ET ± LHRH
  • ET mono ± LHRH
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Where

287 sites
Novartis Investigative Site
Wiener Neustadt, Austria
Novartis Investigative Site
Innsbruck, Austria
Novartis Investigative Site
Linz, Austria
Novartis Investigative Site
Graz, Austria
Novartis Investigative Site
Klagenfurt, Austria
Novartis Investigative Site
Leoben, Austria
Novartis Investigative Site
Schwaz, Austria
Novartis Investigative Site
Steyr, Austria

…and 279 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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