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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-21

Study Completion Date

2029-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Using Application

HR + HER2- BC patients receiving adjuvant ribociclib + AI therapy in routine clinical practice that use the web application

Ribociclib

Intervention Type DRUG

CDK4/6 inhibitor

Letrozole

Intervention Type DRUG

Aromatase inhibitor

Anastrozole

Intervention Type DRUG

Aromatase inhibitor

Non using Application

HR + HER2- BC patients receiving adjuvant ribociclib + AI therapy in routine clinical practice that do not use the web application

Ribociclib

Intervention Type DRUG

CDK4/6 inhibitor

Letrozole

Intervention Type DRUG

Aromatase inhibitor

Anastrozole

Intervention Type DRUG

Aromatase inhibitor

Interventions

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Ribociclib

CDK4/6 inhibitor

Intervention Type DRUG

Letrozole

Aromatase inhibitor

Intervention Type DRUG

Anastrozole

Aromatase inhibitor

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No