NCT06344416 Open Label, Controlled, Post Marketing, Registry Study of Ribociclib (Ribo) Treatment Adherence and Patient Reported Outcomes in Participants Using ReX Technology Platform
| NCT ID | NCT06344416 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dosentrx Ltd. |
| Condition | Any Solid Oral Medication |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-03-30 |
| Primary Completion | 2025-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-03-30 with a primary completion date of 2025-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Primary Objective: • To assess the persistence of ReX technology platform use, measured by the percentage (%) of participants who used ReX: 1) throughout the study period and 2) before the treatment discontinuation. Secondary Objective: • To evaluate the impact of the ReX technology platform on ribo treatment duration and ribo dose taking adherence as compared to control group.
Eligibility 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 \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06344416 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Any Solid Oral Medication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06344416 currently recruiting?
Yes, NCT06344416 is actively recruiting participants. Contact the research team at msummers@dosentrx.com for enrollment information.
Where is the NCT06344416 trial being conducted?
This trial is being conducted at Minneapolis, United States, Austin, United States, Richmond, United States, Madison, United States.
Who is sponsoring the NCT06344416 clinical trial?
NCT06344416 is sponsored by Dosentrx Ltd.. The trial plans to enroll 200 participants.