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)
View Full Details on ClinicalTrials.gov
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NCT06905301
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