Using a digital platform to improve adherence to ribociclib treatment in breast cancer patients
Study of Ribociclib (Ribo) Treatment Adherence Clinical Study Protocol
This study is testing whether a digital platform can help women with HR+ HER2- metastatic breast cancer stick to their ribociclib treatment better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dosentrx Ltd. Industry-sponsored |
| Locations | 4 sites (Minneapolis, Minnesota and 3 other locations) |
| Trial ID | NCT06344416 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the ReX technology platform in enhancing adherence to ribociclib treatment among patients with HR+ HER2- metastatic breast cancer. Participants will use a portable medication dispenser that provides reminders and collects patient-reported outcomes throughout the treatment period. The primary goal is to assess how consistently patients use the ReX platform, while secondary objectives focus on treatment duration and adherence compared to a control group. The study aims to gather data on the impact of this technology on medication management.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with HR+ HER2- metastatic breast cancer who have recently started ribociclib treatment.
Not a fit: Patients who have been taking ribociclib for more than 60 days or those with terminal illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment adherence and outcomes for patients with metastatic breast cancer.
How similar studies have performed: Previous studies have shown promise in using digital platforms for medication adherence, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Male or female, at least 18 years of age. Diagnosis of HR+ HER2- metastatic breast cancer with ribociclib treatment that begun within last 60 days. Site has ability to dispense ribociclib in long term. Participant is able to read, understand and sign the IRB research consent for use of their data for research purposes. Participant is able and willing to complete Patient Reported Outcome (PRO) questionnaires during the study. Exclusion Criteria: • Participant has been routinely taking ribociclib for the past 60 days (without ReX platform). Participants prescribed ribociclib for off-label indications. Participants who failed to pass the learning module during the ReX training process. Participants who are at the end stage of their terminal illness with an anticipated life expectancy of 6 months or less. Participants who have a significant physical disability (including poor fine motor skills, impaired visual or auditory faculties, mental disorders, or another impairment), affecting ability to provide IRB research consent or use the ReX dispensing unit effectively. Participant is unsuited for participation in the study based on PI discretion \-
Where this trial is running
Minneapolis, Minnesota and 3 other locations
- Allina — Minneapolis, Minnesota, United States (Recruiting)
- Texas Oncology — Austin, Texas, United States (Recruiting)
- Virginia Cancer Center — Richmond, Virginia, United States (Recruiting)
- Lumicera — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Mark Summers
- Email: msummers@dosentrx.com
- Phone: +1 612 817 0959
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.