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

NCT07630948 | Not Yet Recruiting Phase 4

• 1 other identifier: ORI2026-20
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Adherence, Medication

Keywords

HR+; HER2-; Early breast cancer; CDK4/6 adherence

Outcome Measures

Primary Outcomes (1)

• 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)

  Randomization to end of treatment with ribociclib: 3 years from enrollment

Secondary Outcomes (2)

• iDFS

  5 years form randomization

• 5-year survival

  5 years form randomization

Study Arms (2)

Intervention arm: structured adherence-support package

EXPERIMENTAL

structured adherence-support package consisting of scheduled reminders, structured educational reinforcement discussion and materials delivered at enrolment and reinforced at specified intervals

Behavioral: Adherence package consisting of additional education and adherence reminders

Control arm: usual care according to local practice

NO INTERVENTION

Control arm: usual care according to local practice (no additional adherence package).

Interventions

Adherence package consisting of additional education and adherence reminders BEHAVIORAL

Adherence package consisting of additional education and adherence reminders

Intervention arm: structured adherence-support package

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Breast Neoplasms; Medication Adherence

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Neza Gros

CONTACT

+386 1 5879 014; ngros@onko-i.si

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RWE adverse events will be collected in scope of this trial. Intervention is behavioral.

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 5, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2032
• Last Updated: June 5, 2026

Record last verified: 2026-06

Locations

SL (1)