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

Sponsor
Institute of Oncology Ljubljana
Study ID
NCT07630948
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adherence package consisting of additional education and adherence reminders — BEHAVIORAL
    Adherence package consisting of additional education and adherence reminders

Study Details

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 Dates

First listed
Jun 5, 2026
Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Sep 1, 2029
Completion
Sep 1, 2032

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Intervention arm: structured adherence-support package
    structured adherence-support package consisting of scheduled reminders, structured educational reinforcement discussion and materials delivered at enrolment and reinforced at specified intervals
  • No Intervention: Control arm: usual care according to local practice
    Control arm: usual care according to local practice (no additional adherence package).

Primary Outcome Measure

Proportion of days covered (PDC) [ Time Frame: Randomization to end of treatment with ribociclib: 3 years from enrollment ]

Central Contacts

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