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)

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: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Letrozole; Drug: Anastrozole; Drug: Ribociclib

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com
• 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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Number (%) of patients who remain on treatment with ribociclib + AI over the 12 months period	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

Outcome Measure	Measure Description	Time Frame
Number of sessions using the web application per month	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	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	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)	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	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	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	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	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	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)	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	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	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

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: March 25, 2025
• First Submitted That Met QC Criteria: March 25, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Breast cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Nitriles; Triazoles; Letrozole; Anastrozole; ribociclib
• Other Study ID Numbers: CLEE011O1RU01