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

NCT06905301 | Recruiting

• 1 other identifier: CLEE011O1RU01
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Breast Cancer

Keywords

Breast cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Number of sessions using the web application per month

  Month 1 - Month 36

• Total duration of sessions (in minutes) per month

  Month 1 - Month 36

• Number of questions to the chatbot per month

  Month 1 - Month 36

• Evaluation of patient satisfaction with the application on a 0-10 visual analog scale (VAS)

  Month 1, 3, 6, 12, 24, 36

• Evaluation of oncologist satisfaction with the application according to a 0-10 VAS

  Month 1, 3, 6, 12, 24, 36

Study Arms (2)

Using Application

HR + HER2- BC patients receiving adjuvant ribociclib + AI therapy in routine clinical practice that use the web application

Drug: Ribociclib; Drug: Letrozole; Drug: Anastrozole

Non using Application

HR + HER2- BC patients receiving adjuvant ribociclib + AI therapy in routine clinical practice that do not use the web application

Drug: Ribociclib; Drug: Letrozole; Drug: Anastrozole

Interventions

Ribociclib DRUG

CDK4/6 inhibitor

Non using Application; Using Application

Letrozole DRUG

Aromatase inhibitor

Non using Application; Using Application

Anastrozole DRUG

Aromatase inhibitor

Non using Application; Using Application

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (7)

Novartis Investigative Site

Pskov, Russia, 180000, Russia

RECRUITING

Novartis Investigative Site

Moscow, 115304, Russia

RECRUITING

Novartis Investigative Site

Saint Petersburg, 194017, Russia

RECRUITING

Novartis Investigative Site

Saint Petersburg, 194291, Russia

RECRUITING

Novartis Investigative Site

Saint Petersburg, 197758, Russia

RECRUITING

Novartis Investigative Site

Sestroretsk, 197706, Russia

RECRUITING

Novartis Investigative Site

Ufa, 450054, Russia

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ribociclib; Letrozole; Anastrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: January 23, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

RU (7)