Status:
RECRUITING
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
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Breast Neoplasms
Eligibility:
All Genders
18-100 years
Brief 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 H...
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- earl...
Eligibility Criteria
Inclusion
- 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
- \- Patient is simultaneously participating in any investigational trial or simultaneously participating in another Novartis-sponsored non-interventional study with ribociclib.
Key Trial Info
Start Date :
February 20 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2030
Estimated Enrollment :
3250 Patients enrolled
Trial Details
Trial ID
NCT06830720
Start Date
February 20 2025
End Date
June 30 2030
Last Update
March 3 2026
Active Locations (267)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Innsbruck, Tyrol, Austria, 6020
2
Novartis Investigative Site
Linz, Upper Austria, Austria, 4010
3
Novartis Investigative Site
Graz, Austria, 8036
4
Novartis Investigative Site
Klagenfurt, Austria, 9020