RecruitingNCT06905301

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


Sponsor

Novartis Pharmaceuticals

Enrollment

240 participants

Start Date

Jan 23, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria5

  • 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.

Exclusion Criteria2

  • 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.

Interventions

DRUGRibociclib

CDK4/6 inhibitor

DRUGLetrozole

Aromatase inhibitor

DRUGAnastrozole

Aromatase inhibitor


Locations(5)

Novartis Investigative Site

Moscow, Russia

Novartis Investigative Site

Saint Petersburg, Russia

Novartis Investigative Site

Saint Petersburg, Russia

Novartis Investigative Site

Saint Petersburg, Russia

Novartis Investigative Site

Ufa, Russia

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NCT06905301


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