Adherence and Safety of Ribociclib Plus Aromatase Inhibitors in Patients With Early Stage, HR+ an… (NCT07630948) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Adherence and Safety of Ribociclib Plus Aromatase Inhibitors in Patients With Early Stage, HR+ and HER2- Breast Cancer
Slovenia90 participantsStarted 2026-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of days covered (PDC)
Timeframe: Randomization to end of treatment with ribociclib: 3 years from enrollment