Using a mobile app to improve sticking with ribociclib plus hormone therapy in stage II–III HR+ HER2‑ breast cancer

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

This project will test whether a mobile app helps people with stage II–III HR+ HER2-negative breast cancer stick to ribociclib plus an aromatase inhibitor.

Quick facts

• Study type: Observational
• Enrollment: 240 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Novartis (Industry-sponsored)
• Locations: 7 sites (Pskov, Russia and 6 other locations)
• Trial ID: NCT06905301 on ClinicalTrials.gov

What this trial studies

This observational study compares retention and adherence to adjuvant ribociclib combined with an aromatase inhibitor in patients with stage II–III hormone receptor–positive, HER2‑negative breast cancer who use a dedicated mobile application versus those who do not. Participants are adults who recently started ribociclib and will be followed in real‑world clinical settings at Novartis investigative sites in Russia. The app provides education about relapse risk, medication reminders, and guidance on preventing and managing side effects, and adherence and retention rates will be collected from clinic records and patient-reported data. The study describes and compares adherence patterns without changing standard clinical care.

Who should consider this trial

Good fit: Adults (male or female) with histologically confirmed, radically treated stage II–III HR+ HER2‑ breast cancer who were prescribed ribociclib plus an aromatase inhibitor (with allowable recent starts as specified) and can provide informed consent are ideal candidates.

Not a fit: Patients enrolled in another interventional trial, those receiving active treatment for other malignancies, people not taking ribociclib, or those unable or unwilling to use a mobile app are unlikely to benefit from this project.

Why it matters

Potential benefit: If successful, the app could increase medication adherence and retention on ribociclib, potentially lowering relapse risk and improving long-term outcomes.

How similar studies have performed: Digital adherence interventions for oral cancer therapies have shown mixed but sometimes positive effects on medication-taking, while direct evidence for app use specifically with ribociclib plus an AI in the adjuvant setting is limited.

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.

Where this trial is running

Pskov, Russia and 6 other locations

• Novartis Investigative Site — Pskov, Russia, Russia (Recruiting)
• Novartis Investigative Site — Moscow, Russia (Recruiting)
• Novartis Investigative Site — Saint Petersburg, Russia (Recruiting)
• Novartis Investigative Site — Saint Petersburg, Russia (Recruiting)
• Novartis Investigative Site — Saint Petersburg, Russia (Recruiting)
• Novartis Investigative Site — Sestroretsk, Russia (Recruiting)
• Novartis Investigative Site — Ufa, Russia (Recruiting)

Study contacts

• Study coordinator: Novartis Pharmaceuticals

Conditions Breast Cancer; Breast cancer