Open Label, Controlled, Post Marketing, Registry Study of Ribociclib (Ribo) Treatment Adherence and Patient Reported Outcomes in Participants Using ReX Technology Platform

Recruiting now · Not applicable

Conditions studied: Any Solid Oral Medication

In brief

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.

Key facts

Study ID

NCT06344416

Run by

Dosentrx Ltd.

People needed

200

Starts

2024-03-30

Expected to finish

2026-01-30

Last updated by the study team

2025-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Allina — Minneapolis, Minnesota, United States (enrolling)
• Texas Oncology — Austin, Texas, United States (enrolling)
• Virginia Cancer Center — Richmond, Virginia, United States (enrolling)
• Lumicera — Madison, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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