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.
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 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
Parallel
Adherence package consisting of additional education and adherence reminders
BehavioralAdherence package consisting of additional education and adherence reminders
Proportion of days covered (PDC)
The primary objective is to show that a structured adherence package increases mean adherence, expressed as days\_taken/days\_prescribed. To maintain comparability with previous studies, we will use the independent samples t test with alpha=0.05 to compare the means between groups. H0: there is no difference in mean PDC between groups (SoC + behavioural intervention vs SoC)
iDFS
estimate invasive disease free survival (iDFS) in both treatment groups
5-year survival
estimate association between adherence and survival
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
