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

Recruiting · NCT06830720 · Observational (researchers observe without assigning treatment) · Lead sponsor: Novartis Pharmaceuticals

View the official record on ClinicalTrials.gov →

Breast cancer

Interventions studied

ET mono ± LHRHabemaciclib + ET ± LHRHribociclib + AI ± LHRH

What this trial is about

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 take part

Age range

18 Years to 100 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not specified

Study type

Observational (researchers observe without assigning treatment)

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.

Where it is running

60 locations listed.

Novartis Investigative Site - Aachen, Germany
Novartis Investigative Site - Amberg, Germany
Novartis Investigative Site - Apolda, Germany
Novartis Investigative Site - Arnsberg, Germany
Novartis Investigative Site - Augsburg, Germany
Novartis Investigative Site - Bad Friedrichshall, Germany
Novartis Investigative Site - Bad Kreuznach, Germany
Novartis Investigative Site - Bad Langensalza, Germany
Novartis Investigative Site - Bad Mergentheim, Germany
Novartis Investigative Site - Bad Reichenhall, Germany
Novartis Investigative Site - Bad Saarow, Germany
Novartis Investigative Site - Bad Soden, Germany
Novartis Investigative Site - Balingen, Germany
Novartis Investigative Site - Bautzen, Germany
Novartis Investigative Site - Bayreuth, Germany
Novartis Investigative Site - Berlin, Germany
Novartis Investigative Site - Berlin, Germany
Novartis Investigative Site - Berlin, Germany
Novartis Investigative Site - Berlin, Germany
Novartis Investigative Site - Berlin, Germany
Novartis Investigative Site - Berlin, Germany
Novartis Investigative Site - Biberach, Germany
Novartis Investigative Site - Bochum, Germany
Novartis Investigative Site - Bonn, Germany
Novartis Investigative Site - Bonn, Germany
Novartis Investigative Site - Bonn, Germany
Novartis Investigative Site - Bottrop, Germany
Novartis Investigative Site - Brandenburg, Germany
Novartis Investigative Site - Bremen, Germany
Novartis Investigative Site - Bremerhaven, Germany
Novartis Investigative Site - Bruchsal, Germany
Novartis Investigative Site - Böblingen, Germany
Novartis Investigative Site - Celle, Germany
Novartis Investigative Site - Chemnitz, Germany
Novartis Investigative Site - Chemnitz, Germany
Novartis Investigative Site - Coburg, Germany
Novartis Investigative Site - Cologne, Germany
Novartis Investigative Site - Dachau, Germany
Novartis Investigative Site - Dessau, Germany
Novartis Investigative Site - Dorfen, Germany
Novartis Investigative Site - Dresden, Germany
Novartis Investigative Site - Dresden, Germany
Novartis Investigative Site - Duisburg, Germany
Novartis Investigative Site - Düsseldorf, Germany
Novartis Investigative Site - Eggenfelden, Germany
Novartis Investigative Site - Ehingen, Germany
Novartis Investigative Site - Ehrenfriedersdorf, Germany
Novartis Investigative Site - Eisenach, Germany
Novartis Investigative Site - Erding, Germany
Novartis Investigative Site - Erfurt, Germany
Novartis Investigative Site - Erfurt, Germany
Novartis Investigative Site - Eschweiler, Germany
Novartis Investigative Site - Essen, Germany
Novartis Investigative Site - Essen, Germany
Novartis Investigative Site - Esslingen am Neckar, Germany
Novartis Investigative Site - Eutin, Germany
Novartis Investigative Site - Freiburg im Breisgau, Germany
Novartis Investigative Site - Friedrichshafen, Germany
Novartis Investigative Site - Friedrichshafen, Germany
Novartis Investigative Site - Fürstenwalde, Germany

Showing 60 of 287 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →