Implementation Study to Describe and Compare Retention Rate and Adherence to Adjuvant Therapy With Ribociclib With and Without Usage of Mobile Application in Patients With HR+ HER2-negative Stage II and III Breast Cancer in Real-world Practice

Study tests app to improve breast cancer treatment adherence

NCT: NCT06905301 · Status: RECRUITING · Phase: N/A · Sponsor: Novartis Pharmaceuticals · Started: 2026-01-23 · Est. Completion: 2029-12-31

Plain English Summary

Implementation Study to Describe and Compare Retention Rate and Adherence to Adjuvant Therapy With Ribociclib With and Without Usage of Mobile Application in Patients With HR+ HER2-negative Stage II and III Breast Cancer in Real-world Practice is a Not Applicable clinical trial sponsored by Novartis Pharmaceuticals studying Breast Cancer. This study looks at how well patients with early-stage breast cancer stick to their treatment when using a mobile app. It's for patients with HR+ HER2-negative stage II and III breast cancer who are prescribed ribociclib. Participation involves using a mobile app designed to help patients stay on track with their medication and understand treatment risks. The alternative is standard treatment without the use of this specific mobile application. The trial aims to enroll 240 participants.

Official Summary

This study is designed to evaluate the effect of using the application on the adherence of patients with luminal HER2- breast cancer (BC) stage II-III to adjuvant therapy with ribociclib in combination with an aromatase inhibitor (AI). The purpose of the app is to increase adherence to treatment by informing patients about the risks of relapse and adverse event prevention and treatment.

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients with stage II-III hormone receptor-positive, HER2-negative breast cancer who have been treated and prescribed ribociclib. Must be 18 years or older. Cannot be currently in another interventional study or receiving active treatment for other cancers. This trial is studying Breast Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The main goal is to see if more patients stay on their prescribed ribociclib treatment for a full year when using a supportive mobile app. The specific primary outcome measures are: Number (%) of patients who remain on treatment with ribociclib + AI over the 12 months period (12 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it aims to improve treatment adherence for early-stage breast cancer patients, addressing a gap in ensuring patients complete their prescribed therapy. This research targets Breast Cancer, where improved treatment options are needed.

Investor Insight

This study, sponsored by Novartis, explores a digital health tool to enhance adherence for a specific breast cancer therapy, potentially improving real-world outcomes and market penetration for riboci

Is This Trial Right for Me?

Ask your doctor if this study is right for you and what the potential benefits and risks of using the app are. You will be asked to use a mobile application regularly to help you manage your treatment. The study will track how often you use the app and your satisfaction with it. This trial is currently recruiting participants. The trial is being conducted at 6 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

1. Female and male patients with histologically verified and radically treated stage II-III hormone receptor positive HER2-negative breast cancer;
2. Age ≥ 18 at the time of initiation of ribociclib therapy;
3. Patients who were prescribed ribociclib + AI (±GnRH agonist for premenopausal men and women) not earlier than 28 days before signing the informed consent;
4. It is allowed to start adjuvant hormone therapy with AI (±GnRH agonist) not earlier than 12 months before the start of ribociclib;
5. Provision of written informed consent.

Exclusion Criteria:

1. Patients participating in any interventional clinical study at the time of signing the informed consent;
2. Patients receiving active treatment for malignant neoplasms other than BC at the time of enrollment.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06905301?

NCT06905301 is a Not Applicable OBSERVATIONAL study titled "Implementation Study to Describe and Compare Retention Rate and Adherence to Adjuvant Therapy With Ribociclib With and Without Usage of Mobile Application in Patients With HR+ HER2-negative Stage II and III Breast Cancer in Real-world Practice." It is currently recruiting and is sponsored by Novartis Pharmaceuticals. The trial targets enrollment of 240 participants.

What conditions does NCT06905301 study?

This trial investigates treatments for Breast Cancer. The primary condition under study is Breast Cancer.

What treatments are being tested in NCT06905301?

The interventions being studied include: Ribociclib (DRUG), Letrozole (DRUG), Anastrozole (DRUG). CDK4/6 inhibitor

What does Not Applicable mean for NCT06905301?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT06905301?

This trial is currently "Recruiting." It started on 2026-01-23. The estimated completion date is 2029-12-31.

Who is sponsoring NCT06905301?

NCT06905301 is sponsored by Novartis Pharmaceuticals. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06905301?

The trial aims to enroll 240 participants. The trial is currently recruiting and accepting new participants.

How is NCT06905301 designed?

This is a observational study.

What are the primary outcomes being measured in NCT06905301?

The primary outcome measures are: Number (%) of patients who remain on treatment with ribociclib + AI over the 12 months period (12 months). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06905301 being conducted?

This trial is being conducted at 6 sites, including Pskov, Russia; Moscow; Saint Petersburg; Ufa and 2 more sites (Russia).

Where can I find official information about NCT06905301?

The official record for NCT06905301 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06905301. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06905301 testing in simple terms?

This study looks at how well patients with early-stage breast cancer stick to their treatment when using a mobile app. It's for patients with HR+ HER2-negative stage II and III breast cancer who are prescribed ribociclib.

Why is this trial significant?

This trial matters because it aims to improve treatment adherence for early-stage breast cancer patients, addressing a gap in ensuring patients complete their prescribed therapy.

What are the potential risks of participating in NCT06905301?

Potential side effects of ribociclib and aromatase inhibitors can include fatigue, nausea, and changes in blood counts. The mobile app may not be effective for everyone in improving adherence. Risks associated with app usage could include data privacy concerns, though these are typically managed with informed consent. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06905301?

Ask your doctor if this study is right for you and what the potential benefits and risks of using the app are. You will be asked to use a mobile application regularly to help you manage your treatment. The study will track how often you use the app and your satisfaction with it. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06905301 signal from an investment perspective?

This study, sponsored by Novartis, explores a digital health tool to enhance adherence for a specific breast cancer therapy, potentially improving real-world outcomes and market penetration for riboci This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participation involves using a mobile app designed to help patients stay on track with their medication and understand treatment risks. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.