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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +41613241111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.