Adherence and Safety of Ribociclib Plus Aromatase Inhibitors in Patients With Early Stage, HR+ and HER2- Breast Cancer

Starting soon · Phase 4

Conditions studied: Breast Cancer, Adherence, Medication

In brief

Breast cancer is the most common malignancy in women, with HR+/HER2- early breast cancer accounting for approximately 70% of cases. Although adjuvant endocrine therapy substantially reduces the risk of recurrence, a clinically meaningful proportion of patients, particularly those with intermediate- and high-risk disease, still experience relapse. The addition of CDK4/6 inhibitors such as ribociclib to endocrine therapy has demonstrated significant improvement in invasive disease-free survival (iDFS) and is now part of standard adjuvant treatment for selected patients. However, the real-world effectiveness of prolonged oral therapy depends heavily on patient adherence, which may be negatively affected by treatment duration, adverse events, and the absence of immediate perceived benefit. Evidence regarding adherence to adjuvant ribociclib therapy in routine clinical practice remains limited. This study therefore aims to evaluate whether a structured adherence-support intervention can improve treatment adherence during ribociclib therapy and to explore the relationship between adherence and long-term clinical outcomes, including iDFS.

Key facts

Study ID

NCT07630948

Run by

Institute of Oncology Ljubljana

People needed

90

Starts

2026-09-01

Expected to finish

2032-09-01

Last updated by the study team

2026-06-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Female or male patient prescribed with ribociclib in combination with an aromatase inhibitor independently of trial participation
• Patient was prescribed ribociclib independently of this trial protocol and has not yet started cycle 1
• Patient is ≥ 18 years-old at the time of ICF signature
• Patient has mandatory Slovenian health insurance
• Patient understands and speaks Slovenian language and is of congitive capability to participate in the trial
• Patient has access to phone
• Patient voluntarily agrees to participate in the trial and provides written ICF

You may not qualify if…

• Patient is not treated with the combination of ribociclib and aromatase inhibitor for Early BC
• Metastatic Hormone Receptor positive and HER2- negative BC
• Any medical condition that, in the opinion of the investigator, would interfere with adherence participation in the trial (i.e. significant cognitive impairment, psychiatric condition)
• Language barrier that precludes informed consent or meaningful participation in the adherence intervention

Where it is running

• Institute of Oncology Ljubljana — Ljubljana, Slovenia

Full record on ClinicalTrials.gov

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