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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

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.

ClinicalTrials.gov IDNCT06830720

PhaseNot Applicable

Enrollment3250

SponsorNovartis Pharmaceuticals

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Breast Neoplasms

About this study

Interventions

Drug: ribociclib + AI ± LHRH — ribociclib in combination with an aromatase inhibitor ± LHRH as described in the current effective summary of product characteristics. This is an observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.
Drug: abemaciclib + ET ± LHRH — abemaciclib in combination with an endocrine therapy ± LHRH as described in the current effective summary of product characteristics. This is an observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.
Drug: ET mono ± LHRH — endocrine monotherapy ± LHRH. This is an observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.

Primary outcomes

Invasive disease-free survival (iDFS) for adjuvant therapy with ribociclib + AI ± LHRH in participants with HR+/HER2- eBC at high risk of recurrence (36 months)

Eligibility information

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.

Study locations

Novartis Investigative Site, Wiener Neustadt, Lower Austria 2700 Austria
Novartis Investigative Site, Innsbruck, Tyrol 6020 Austria
Novartis Investigative Site, Linz, Upper Austria 4010 Austria
Novartis Investigative Site, Graz, 8036 Austria
Novartis Investigative Site, Klagenfurt, 9020 Austria
Novartis Investigative Site, Leoben, 8700 Austria
Novartis Investigative Site, Schwaz, 6130 Austria
Novartis Investigative Site, Steyr, 4400 Austria
Novartis Investigative Site, Vienna, 1090 Austria
Novartis Investigative Site, Vienna, 1130 Austria

Showing 10 of 287 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.