Recruiting

Ribociclib

Sponsor:

Dosentrx Ltd.

Code:

NCT06344416

Conditions

Any Solid Oral Medication

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Use of ReX to dispense and monitor solid oral medication therapy.

Study Details

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.

Conditions

Any Solid Oral Medication

Study ID

NCT06344416

Start date

Mar 30, 2024

Status verified date

Aug, 2024

Completion date

Jan 30, 2026

Anticipated

Primary completion date

Mar 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

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Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Control Study Group

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.

experimental: ReX Platform Study Group

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.

Interventions

Use of ReX to dispense and monitor solid oral medication therapy.

ReX Remote Digital Nurse comprising hand-held dispenser, disposable drug cartridge and web application (ReX Treatment Manager).

Primary outcome measure

  • Outcome MeasureReX Platform Study Group [ Time Frame: Up to 12 months ]

Central Contacts and Locations

Central contacts

Mark Summers

+1 612 817 0959msummers@dosentrx.com

Locations

Allina

Recruiting

Minneapolis, Minnesota, United States, 55407

Texas Oncology

Recruiting

Austin, Texas, United States, 78705

Virginia Cancer Center

Recruiting

Richmond, Virginia, United States, 23229

Lumicera

Recruiting

Madison, Wisconsin, United States, 53717

More Information

Sponsor

Dosentrx Ltd.

Last update posted

Mar 12, 2025

Last verified

Aug, 2024

Keywords

  • Solid oral medication

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Dosentrx Ltd. on 2025-03-12.