Actively Recruiting
Open Label, Controlled, Post Marketing, Registry Study of Ribociclib (Ribo) Treatment Adherence and Patient Reported Outcomes in Participants Using ReX Technology Platform
Led by Dosentrx Ltd. · Updated on 2025-03-12
200
Participants Needed
4
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Open Label, Controlled, Post Marketing, Registry Study of Ribociclib (Ribo) Treatment Adherence and Patient Reported Outcomes in Participants Using ReX Technology Platform
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female at least 18 years old
- Diagnosed with HR+ HER2- metastatic breast cancer
- Started ribociclib treatment within the last 60 days
- Site able to dispense ribociclib long term
- Able to read, understand, and sign consent for research
- Willing and able to complete Patient Reported Outcome questionnaires during the study
You will not qualify if you...
- Routinely taking ribociclib for the past 60 days without using ReX platform
- Ribociclib prescribed for off-label use
- Failed to complete ReX training learning module
- At end stage of terminal illness with life expectancy of 6 months or less
- Significant physical disability affecting ability to consent or use ReX dispenser
- Deemed unsuitable for study participation by the principal investigator
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Allina
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
2
Texas Oncology
Austin, Texas, United States, 78705
Actively Recruiting
3
Virginia Cancer Center
Richmond, Virginia, United States, 23229
Actively Recruiting
4
Lumicera
Madison, Wisconsin, United States, 53717
Actively Recruiting
Research Team
M
Mark Summers
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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