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 (IMPULSE)

April 29, 2026 updated by: Novartis Pharmaceuticals
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Novartis Pharmaceuticals

Study Locations

  • Russia
      • Moscow, Russia, 115304
        • Recruiting
        • Novartis Investigative Site
      • Saint Petersburg, Russia, 194291
        • Recruiting
        • Novartis Investigative Site
      • Saint Petersburg, Russia, 194017
        • Recruiting
        • Novartis Investigative Site
      • Saint Petersburg, Russia, 197758
        • Recruiting
        • Novartis Investigative Site
      • Sestroretsk, Russia, 197706
        • Recruiting
        • Novartis Investigative Site
      • Ufa, Russia, 450054
        • Recruiting
        • Novartis Investigative Site
    • Russia
      • Pskov, Russia, Russia, 180000
        • Recruiting
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with HR+ HER2- stage II-III breast cancer who have started treatment with ribociclib + AI (± GnRH agonist for premenopausal men and women) will be enrolled in the study

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Using Application
HR + HER2- BC patients receiving adjuvant ribociclib + AI therapy in routine clinical practice that use the web application
Drug: Letrozole
Aromatase inhibitor
Drug: Anastrozole
Aromatase inhibitor
Drug: Ribociclib
CDK4/6 inhibitor
Non using Application
HR + HER2- BC patients receiving adjuvant ribociclib + AI therapy in routine clinical practice that do not use the web application
Drug: Letrozole
Aromatase inhibitor
Drug: Anastrozole
Aromatase inhibitor
Drug: Ribociclib
CDK4/6 inhibitor

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number (%) of patients who remain on treatment with ribociclib + AI over the 12 months period
Time Frame: 12 months
The difference between the two groups (App and non-App) in number (%) of patients who remain on treatment with ribociclib + AI over the 12 months period (excluding patients who discontinued treatment due to AE, disease relapse, or death)
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of sessions using the web application per month
Time Frame: Month 1 - Month 36
To describe the rate of the web application usage in the group of patients who use the web application.
Month 1 - Month 36
Total duration of sessions (in minutes) per month
Time Frame: Month 1 - Month 36
To describe the rate of the web application usage in the group of patients who use the web application.
Month 1 - Month 36
Number of questions to the chatbot per month
Time Frame: Month 1 - Month 36
To describe the rate of the web application usage in the group of patients who use the web application.
Month 1 - Month 36
Evaluation of patient satisfaction with the application on a 0-10 visual analog scale (VAS)
Time Frame: Month 1, 3, 6, 12, 24, 36
Evaluation of patient satisfaction with the application on a 0-10 VAS, where 0 is for completely dissatisfied, 10 is for completely satisfied in M1, M3, M6, M12, M24, M36
Month 1, 3, 6, 12, 24, 36
Evaluation of oncologist satisfaction with the application according to a 0-10 VAS
Time Frame: Month 1, 3, 6, 12, 24, 36
Evaluation of oncologist satisfaction with the application according to a 0-10 VAS, where 0 is for completely dissatisfied, 10 is for completely satisfied in M1, M3, M6, M12, M24, M36
Month 1, 3, 6, 12, 24, 36
Number of patients in each response category according to the questionnaire on quality of life
Time Frame: Month 1, 3, 6, 12, 24, 36
The number (%) of patients in each response category (no problems, mild problems, moderate problems, severe problems, and extremely severe problems) according to the questionnaire scale (mobility, self-care, normal activities, pain/discomfort, anxiety/depression) in M1, M3, M6, M12, M24, M36 in the groups using and not using the web application
Month 1, 3, 6, 12, 24, 36
VAS score according to the questionnaire on quality of life
Time Frame: Month 1, 3, 6, 12, 24, 36
VAS score according to the questionnaire (VAS 0-100, where 0 is the worst health state and 100 is the best health state) at M1, M3, M6, M12, M24, and M36 in both app user and non-app user groups
Month 1, 3, 6, 12, 24, 36
Assessment of patient satisfaction with treatment
Time Frame: Month 3, 6, 12, 24, 36
Assessment of patient satisfaction with treatment (VAS 0-10, where 0 is completely dissatisfied, and 10 is completely satisfied) at M3, M6, M12, M24, and M36 in both app user and non-app user groups
Month 3, 6, 12, 24, 36
Dose intensity
Time Frame: Month 3, 6, 12, 24, 36
Dose intensity (% of missed doses as assessed by the patient, except for therapy suspension due to AE) at M3, M6, M12, M24, and M36 in both app user and non-app user groups
Month 3, 6, 12, 24, 36
Number of patients with adverse events (AE)
Time Frame: Month 3, 6, 12, 24, 36
The percentage (%) of patients with AE (cumulative and depending on the severity) at M3, M6, M12, M24, and M36 in both app user and non-app user groups
Month 3, 6, 12, 24, 36
Number of patients with dose reduction and/or discontinuation of ribociclib therapy due to progression, death for breast cancer, death from another cause, other AE
Time Frame: Month 3, 6, 12, 24, 36
The percentage (%) of patients with dose reduction and/or discontinuation of ribociclib therapy due to progression, death for breast cancer, death from another cause, other AE at M3, M6, M12, M24, and M36 in both app user and non-app user groups
Month 3, 6, 12, 24, 36
Number of patients by age, education, occupation, TNM (tumor, nodus, metastasis) stage, tumor grade (G), Ki67 level in both app user and non-app user groups
Time Frame: Baseline
Proportion (%) of patients by age, education, occupation, TNM (tumor, nodus, metastasis) stage, tumor grade (G), Ki67 level in both app user and non-app user groups
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 23, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLEE011O1RU01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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