Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
The ReX Platform is a class 1 FDA listed device under product code NXB Dispenser Solid Medication as a device that meets the exempt regulation 21 CFR 890.5050. and comprises the following components:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Study Group | Experimental | The control group of the study is designed to capture baseline data especially regarding ribo therapy duration of patients prescribed with ribociclib. Data will be collected by reviewing historical patient records as captured within the electronic medical record (chart review) by recording demographics, International Classification of Diseases (ICD-10) codes, prescription fill rates and Current Procedural Terminology (CPT) codes. De-identified data of patients treated with ribociclib for HR+/HER2 negative metastatic Breast Cancer (mBC) during June 2022 to April 2024 and collated in a de-identified database by Dosentrx will be retrospectively analyzed. The results of the treatment duration for these participants will be used as a baseline for the ReX study group. A minimum of 50 and a maximum of 200 patient charts are expected to be reviewed for the control study group. |
|
| ReX Platform Study Group | Experimental | The ReX platform study group will utilize data, collected from the same study sites that were chosen for control study group. A database consisting of at least fifty (50) female and male participants who initiated ribociclib for metastatic breast cancer and signed IRB research consent will be used for ReX study group. This group will include participants who started the recommended ribo dose of 600 mg QD and additional doses, delivered by the ReX technology platform. Physical examinations and laboratory tests will be performed in accordance with routine clinical practice; however, these parameters will not be collected for the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of ReX to dispense and monitor solid oral medication therapy. | Device | ReX Remote Digital Nurse comprising hand-held dispenser, disposable drug cartridge and web application (ReX Treatment Manager). |
| Measure | Description | Time Frame |
|---|---|---|
| Outcome MeasureReX Platform Study Group | Numerical variables will be tabulated using mean, standard deviation, minimum, median, maximum and number of observations. Categorical variables will be tabulated using number of observations and percentages. Two interim analyses are planned for this study: Interim analysis no. 1 will summarize 50 reviewed patient charts from the control group (completed as for January 2024) Interim analysis no. 2 will summarize about 25-30 participants from the ReX group, who used ReX for at least 1 month, and will compare them to control group (planned for April 2024). | Up to 12 months |
Not provided
Not provided
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
-
Male or female, at least 18 years of age.
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark Summers | Contact | +1 612 817 0959 | msummers@dosentrx.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allina | Recruiting | Minneapolis | Minnesota | 55407 | United States | |
| Texas Oncology |
Not provided
| Label | URL |
|---|---|
| Website of ReX Remote Digital Nurse | View source |
Not provided
Not provided
Study groups
Not provided
Not provided
A minimum of 50 and a maximum of 200 patient charts are expected to be reviewed for the control study group.
| Recruiting |
| Austin |
| Texas |
| 78705 |
| United States |
| Virginia Cancer Center | Recruiting | Richmond | Virginia | 23229 | United States |
| Lumicera | Recruiting | Madison | Wisconsin | 53717 | United States |