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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 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.

ClinicalTrials.gov IDNCT06905301

PhaseNot Applicable

Enrollment240

SponsorNovartis Pharmaceuticals

Age18 Years

SexALL

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Conditions studied

Breast Cancer

About this study

Interventions

Drug: Ribociclib — CDK4/6 inhibitor
Drug: Letrozole — Aromatase inhibitor
Drug: Anastrozole — Aromatase inhibitor

Primary outcomes

Number (%) of patients who remain on treatment with ribociclib + AI over the 12 months period (12 months)

Eligibility information

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.

Study locations

Novartis Investigative Site, Pskov, Russia 180000 Russia
Novartis Investigative Site, Moscow, 115304 Russia
Novartis Investigative Site, Saint Petersburg, 194017 Russia
Novartis Investigative Site, Saint Petersburg, 194291 Russia
Novartis Investigative Site, Saint Petersburg, 197758 Russia
Novartis Investigative Site, Sestroretsk, 197706 Russia
Novartis Investigative Site, Ufa, 450054 Russia

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.