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

Recruiting now

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT06905301

Run by

Novartis Pharmaceuticals

People needed

240

Starts

2026-01-23

Expected to finish

2029-12-31

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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