Last Update: Feb 05, 2026
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
ClinicalTrials.gov Identifier:
Novartis Reference Number:CLEE011O1RU01
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

Breast Cancer
Recruiting
240
Jan 21, 2026
Dec 31, 2029
All
18 Years - 90 Years (Adult, Older Adult)

Interventions

Drug

Anastrozole

Aromatase inhibitor
Drug

Letrozole

Aromatase inhibitor
Drug

Ribociclib

CDK4/6 inhibitor

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.

Novartis Investigative Site

Recruiting

Moscow,115304,Russia

Novartis Investigative Site

Recruiting

Saint Petersburg,194017,Russia

Novartis Investigative Site

Recruiting

Saint Petersburg,194291,Russia

Novartis Investigative Site

Recruiting

Saint Petersburg,197758,Russia

Novartis Investigative Site

Recruiting

Ufa,450054,Russia

Worldwide Contacts

If the location of your choosing does not feature any contact detail, please reach out using the information below.

Novartis Pharmaceuticals