ReX Technology for Pill Adherence

Recruiting at 5 trial locations

Overseen By Mark Summers

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dosentrx Ltd.

Must be taking: Ribociclib

Disqualifiers: End stage illness, Physical disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 12 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the ReX technology platform to determine if it helps people adhere better to their ribociclib treatment plan. Ribociclib treats HR+ HER2- metastatic breast cancer. The trial compares two groups: one using the ReX platform and a control group, to assess if the ReX platform improves medication adherence in terms of duration and quality. Individuals who began ribociclib treatment within the last 60 days and have this specific type of breast cancer may qualify for the trial. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance treatment adherence for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it focuses on participants who are starting ribociclib treatment, so you may need to continue with ribociclib if you are already on it.

What prior data suggests that the ReX technology platform is safe for use in this study?

Research shows that the ReX Technology Platform is used with ribociclib, a drug for certain types of breast cancer. Ribociclib has been studied extensively and is generally safe and effective for people with hormone receptor-positive, HER2-negative metastatic breast cancer.

In past studies, ribociclib was well-tolerated. Most patients did not experience severe side effects. Some had mild issues like tiredness, nausea, or changes in blood counts, but these were manageable.

The ReX Technology Platform aids in medication adherence. No reports indicate safety issues with using this platform. As it is not a drug, it does not have side effects like medicines do.

Overall, ribociclib has a good safety record, and the ReX Technology Platform appears to be a helpful addition without known risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ReX Technology Platform because it offers a new way to enhance pill adherence for patients with metastatic breast cancer, specifically those on ribociclib. Unlike traditional methods that rely heavily on patient self-management, ReX leverages technology to ensure that patients consistently take their medication as prescribed, potentially improving treatment outcomes. By using a technology-driven approach, ReX aims to address one of the significant challenges in cancer treatment—ensuring patients follow their medication regimen correctly—thereby maximizing the effectiveness of ribociclib therapy.

What evidence suggests that the ReX technology platform is effective for improving pill adherence in metastatic breast cancer patients?

Previous studies have shown that ribociclib effectively treats hormone receptor-positive, HER2-negative metastatic breast cancer, helping patients live longer without disease progression. It has also proven beneficial for patients with early breast cancer, extending the time without disease recurrence. This trial examines the ReX Technology Platform to assist patients in taking ribociclib as prescribed. Although specific data on ReX is limited, following medication instructions typically leads to better treatment outcomes. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for patients who are prescribed Ribociclib, a pill used to treat certain conditions. Participants must be willing to use the ReX technology platform, which helps dispense and monitor their medication therapy.

Inclusion Criteria

My treatment center can provide long-term access to ribociclib.

I am willing and able to fill out questionnaires about my health during the study.

I started treatment with ribociclib for my HR+ HER2- metastatic breast cancer within the last 60 days.

Exclusion Criteria

Participants who are at the end stage of their terminal illness with an anticipated life expectancy of 6 months or less

I have been taking ribociclib regularly for the last 60 days.

I am taking ribociclib for a condition not listed on the label.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the ReX technology platform to manage ribociclib treatment adherence and report outcomes

Up to 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ReX Technology Platform

Trial Overview The study is testing how well people stick with using the ReX technology platform over time and whether it affects how long they stay on Ribociclib treatment and how well they follow their dosing schedule compared to those not using ReX.

How Is the Trial Designed?

Group I: ReX Platform Study Group Experimental Treatment 1 Intervention

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.

Group II: Control Study Group Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Dosentrx Ltd.

Lead Sponsor

Trials

6

Recruited

1,400+

Published Research Related to This Trial

Ribociclib is an oral medication that inhibits CDK 4 and 6, leading to cell cycle arrest in cancer cells, and has been approved in the USA for treating advanced breast cancer in combination with an aromatase inhibitor.

The drug is currently undergoing further phase III trials for breast cancer and is being tested in early-phase trials for other types of solid tumors and blood cancers, highlighting its potential as a versatile cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ribociclib: First Global Approval. Syed, YY.[2018]

A new method called co-encapsulation (CoE) combines oral medications with an edible ingestion sensor (IS) to create 'digitized' medications that accurately track when patients take their medicine, enhancing medication adherence.

In a study involving 12 patients with active tuberculosis, the CoE-IS-Rifamate showed bioequivalence to the standard Rifamate formulation, meaning it works just as effectively without compromising the quality of the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digitizing Medicines for Remote Capture of Oral Medication Adherence Using Co-encapsulation. Browne, SH., Peloquin, C., Santillo, F., et al.[2019]

The Ingestible Sensor System (ISS) demonstrated 100% accuracy in detecting the ingestion of oral medications in a study of 20 kidney transplant patients over an average of 9.2 weeks, indicating its potential for improving treatment adherence.

While the ISS showed high adherence rates (99.4%) and no serious adverse events, some patients experienced gastrointestinal symptoms and skin irritation from the monitoring device, highlighting the need for careful patient management during use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication adherence assessment: high accuracy of the new Ingestible Sensor System in kidney transplants. Eisenberger, U., Wüthrich, RP., Bock, A., et al.[2022]

Ribociclib, approved by the FDA for treating advanced breast cancer, significantly improves progression-free survival when combined with letrozole compared to a placebo, as shown in a study of 668 patients.

The overall response rate for patients receiving ribociclib plus letrozole was 52.7%, compared to 37.1% for those on placebo, indicating its efficacy, although common side effects included neutropenia and nausea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval: Ribociclib for the Treatment of Postmenopausal Women with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer. Shah, A., Bloomquist, E., Tang, S., et al.[2019]

The ReX medication management system significantly improved adherence rates, achieving 97.6% adherence compared to 76.3% with standard packaging, demonstrating its efficacy in enhancing medication compliance.

The ReX system was well-accepted and easy to use, with 87% of subjects finding it user-friendly and no adverse events reported during the studies, indicating its safety for patient use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Digital Medication Management System for Effective Assessment and Enhancement of Patient Adherence to Therapy (ReX): Feasibility Study. Shtrichman, R., Conrad, S., Schimo, K., et al.[2020]

In a study of 554 Italian patients with hormone receptor-positive, HER2-negative advanced breast cancer, ribociclib combined with letrozole showed a clinical benefit rate of 71.7% and a median time to progression of 26.7 months, indicating effective treatment outcomes.

The treatment was associated with manageable safety profiles, with 98.9% of patients experiencing all-grade adverse events, primarily neutropenia, but health-related quality of life scores remained stable during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ribociclib in Combination with Letrozole in Patients with HR+, HER2- Advanced Breast Cancer: Results from the Italian Subpopulation of Phase 3b CompLEEment-1 Study. De Laurentiis, M., Caputo, R., Mazza, M., et al.[2022]

Accurate measurement of medication adherence is crucial for effective patient care and evaluating treatment options, with electronic methods now being the standard for tracking dosing history.

Inadequate adherence is often underestimated, leading to unrecognized treatment failures and potential toxicity from missed doses, highlighting the need for standardized terminology and methods in adherence assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to medications: insights arising from studies on the unreliable link between prescribed and actual drug dosing histories. Blaschke, TF., Osterberg, L., Vrijens, B., et al.[2022]

In a study of 79 patients taking metformin, those with less than 80% adherence who received cue-dose training showed a significant improvement in medication adherence by 15% over 4 months.

While cue-dose training improved adherence to metformin, it did not significantly affect adherence to other antihyperglycemic medications, and there was no difference in blood sugar control between the groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic monitoring and counseling to improve medication adherence. Rosen, MI., Rigsby, MO., Salahi, JT., et al.[2013]

In a study of 693 young women with hormone receptor-positive breast cancer, 9% did not start oral adjuvant endocrine therapy (ET) within 18 months, with Black women showing higher odds of non-initiation.

Among those who started ET, 20% were non-persistent, with factors like younger age and marital status influencing adherence; however, non-persistence was linked to lower recurrence rates, suggesting that decision-making support could enhance adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant endocrine therapy non-initiation and non-persistence in young women with early-stage breast cancer. Rosenberg, SM., Zheng, Y., Gelber, S., et al.[2023]

Poor medication adherence affects about 50% of patients with chronic diseases, leading to variability in drug effectiveness and safety, which is a significant challenge for precision medicine.

A new cross-technology platform using edible ingestion sensors can accurately measure medication adherence by linking pharmacokinetic models with real-time data on drug ingestion, potentially improving drug development and clinical trial outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A New Approach to Measure Adherence to Medicines Using Biomarkers and Sensors. Özdemir, V., Endrenyi, L.[2020]

Ribociclib, a CDK4/6 inhibitor, has shown safety and efficacy when used with endocrine therapy for advanced breast cancer, with a bioavailability of 65.8% for the oral 600-mg tablet.

The study confirmed that the oral tablet and capsule formulations of ribociclib are bioequivalent, with no serious adverse events reported, indicating a reliable and safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Absolute Oral Bioavailability and Bioequivalence of Ribociclib, a Cyclin-Dependent Kinase 4/6 Inhibitor, in Healthy Subjects. Ji, Y., Abdelhady, AM., Samant, TS., et al.[2021]

A study of breast cancer patients showed that those using mail order pharmacies had higher adherence to their endocrine therapy, especially when copayments were low and 90-day prescriptions were available.

For patients using local pharmacies, adherence was better when they used a single pharmacy and had synchronized medication refills, highlighting the importance of medication delivery methods and costs in treatment adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication delivery factors and adjuvant endocrine therapy adherence in breast cancer. Neuner, JM., Fergestrom, N., Pezzin, LE., et al.[2023]

Adherence to prescribed drug dosages is crucial for accurately estimating the dose-response relationship in clinical studies, as non-compliance can introduce variability that complicates results.

A networked system with an ingestible sensor demonstrated a high detection accuracy of 99.3% for confirming drug ingestion, allowing for better assessment of actual dosing patterns and their impact on drug efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role for direct electronic verification of pharmaceutical ingestion in pharmaceutical development. DiCarlo, LA.[2012]

Ribociclib, a CDK 4/6 inhibitor, significantly improves median progression-free survival (PFS) in women with HR+/HER2- metastatic breast cancer when used in combination with endocrine therapy, with PFS ranging from 8 to 13 months across three phase III trials.

The treatment is well tolerated, particularly in elderly patients, and while it has some dose-limiting toxicities like neutropenia and QTc prolongation, it maintains health-related quality of life and reduces pain scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ribociclib in HR+/HER2- Advanced or Metastatic Breast Cancer Patients. Rascon, K., Flajc, G., De Angelis, C., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30522347/

Ribociclib in HR+/HER2- Advanced or Metastatic Breast ... Ribociclib, when added to endocrine therapy, significantly improves PFS and has manageable toxicity in premenopausal/perimenopausal and postmenopausal women ...

2. us.kisqali.com us.kisqali.com/metastatic-breast-cancer/proven-results/results-with-kisqali

Clinical Trial Results | mBC Review clinical trial results in women living with HR+, HER2- metastatic breast cancer who were treated with KISQALI. See full Prescribing and Safety Info.

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Adjuvant Ribociclib Plus AI Therapy Has Long-Term ... Ribociclib plus AI significantly improved iDFS in hormone receptor–positive, HER2-negative early breast cancer patients compared to AI alone, ...

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Five-Year NATALEE Data Show Ribociclib Improves ... New data from the NATALEE trial reveals ribociclib significantly improves invasive disease-free survival in HR+/HER2– early breast cancer.

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6. clinicaltrials.gov clinicaltrials.gov/study/NCT06344416

Study Details | NCT06344416 | Open Label, Controlled ... 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 ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06344416/open-label-controlled-post-marketing-registry-study-of-ribociclib-ribo-treatment-adherence-and-patient-reported-outcomes-in-participants-using-rex-technology-platform

Open Label, Controlled, Post Marketing, Registry Study of ... To evaluate the impact of the ReX technology platform on ribo treatment duration and ribo dose taking adherence as compared to control group.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02941926

NCT02941926 | Study to Assess the Safety and Efficacy of ... The purpose of this study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40535397/

Real-World Outcomes of Ribociclib Treatment in Patients ... Conclusion Our retrospective data support the notion that ribociclib-based therapy is effective and safe in patients with HR+/HER2- ABC/MBC; ...