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Evaluating ribociclib with aromatase inhibitors for early breast cancer treatment

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 to Evaluate Real-world Effectiveness, Safety Profile, Patient Compliance and Quality of Life

Observational Novartis · NCT06830720

This study is testing if combining ribociclib with an aromatase inhibitor can help people with early breast cancer feel better and reduce their risk of the cancer coming back.

Quick facts

Study typeObservational
Enrollment3250 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorNovartis Industry-sponsored
Locations279 sites (Wiener Neustadt, Lower Austria and 278 other locations)
Trial IDNCT06830720 on ClinicalTrials.gov

What this trial studies

This observational study assesses the real-world effectiveness and safety of ribociclib combined with an aromatase inhibitor for patients with HR+/HER2- early breast cancer who are at high risk of recurrence. It aims to gather data on patient compliance, quality of life, and management of adverse events. The study will also compare outcomes with patients receiving other treatment regimens, including abemaciclib and endocrine therapy. Conducted across various breast centers in Germany, it seeks to provide insights into the clinical adoption of ribociclib after its EU approval.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with HR+/HER2- early breast cancer who are at high risk of recurrence and are eligible for treatment with ribociclib and an aromatase inhibitor.

Not a fit: Patients with HR-/HER2+ breast cancer or those not indicated for ribociclib treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance treatment strategies for patients with high-risk early breast cancer, potentially improving their outcomes.

How similar studies have performed: Other studies have shown promise with similar treatment approaches, but this specific combination is being evaluated in a real-world setting.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Wiener Neustadt, Lower Austria and 278 other locations

+229 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast NeoplasmsNon-interventional studyNISbreast cancerearly breast cancerHR+HER-ribociclib
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.