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

Not yet recruiting

• Conditions: Breast Cancer
• Interventions: Drug: Ribociclib; Drug: Letrozole; Drug: Anastrozole

• Registration Number: NCT06905301
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-25
• Study First Submitted QC: 2025-03-25
• Last Update Submitted: 2025-03-25
• Study First Posted: 2025-04-01
• Last Update Posted: 2025-04-01
• Study Start: 2025-07-31
• Primary Completion: 2029-07-01
• Study Completion: 2029-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Using Application	Ribociclib	HR + HER2- BC patients receiving adjuvant ribociclib + AI therapy in routine clinical practice that use the web application
Using Application	Letrozole	HR + HER2- BC patients receiving adjuvant ribociclib + AI therapy in routine clinical practice that use the web application
Using Application	Anastrozole	HR + HER2- BC patients receiving adjuvant ribociclib + AI therapy in routine clinical practice that use the web application
Non using Application	Ribociclib	HR + HER2- BC patients receiving adjuvant ribociclib + AI therapy in routine clinical practice that do not use the web application
Non using Application	Letrozole	HR + HER2- BC patients receiving adjuvant ribociclib + AI therapy in routine clinical practice that do not use the web application
Non using Application	Anastrozole	HR + HER2- BC patients receiving adjuvant ribociclib + AI therapy in routine clinical practice that do not use the web application

Primary Outcome Measures

Name	Time	Method
Number (%) of patients who remain on treatment with ribociclib + AI over the 12 months period	12 months	The difference between the two groups (App and non-App) in number (%) of patients who remain on treatment with ribociclib + AI over the 12 months period (excluding patients who discontinued treatment due to AE, disease relapse, or death)

Secondary Outcome Measures

Name	Time	Method
Number of sessions using the web application per month	Month 1 - Month 36	To describe the rate of the web application usage in the group of patients who use the web application.
Total duration of sessions (in minutes) per month	Month 1 - Month 36	To describe the rate of the web application usage in the group of patients who use the web application.
Number of questions to the chatbot per month	Month 1 - Month 36	To describe the rate of the web application usage in the group of patients who use the web application.
Evaluation of patient satisfaction with the application on a 0-10 visual analog scale (VAS)	Month 1, 3, 6, 12, 24, 36	Evaluation of patient satisfaction with the application on a 0-10 VAS, where 0 is for completely dissatisfied, 10 is for completely satisfied in M1, M3, M6, M12, M24, M36
Evaluation of oncologist satisfaction with the application according to a 0-10 VAS	Month 1, 3, 6, 12, 24, 36	Evaluation of oncologist satisfaction with the application according to a 0-10 VAS, where 0 is for completely dissatisfied, 10 is for completely satisfied in M1, M3, M6, M12, M24, M36
Number of patients in each response category according to the questionnaire on quality of life	Month 1, 3, 6, 12, 24, 36	The number (%) of patients in each response category (no problems, mild problems, moderate problems, severe problems, and extremely severe problems) according to the questionnaire scale (mobility, self-care, normal activities, pain/discomfort, anxiety/depression) in M1, M3, M6, M12, M24, M36 in the groups using and not using the web application
VAS score according to the questionnaire on quality of life	Month 1, 3, 6, 12, 24, 36	VAS score according to the questionnaire (VAS 0-100, where 0 is the worst health state and 100 is the best health state) at M1, M3, M6, M12, M24, and M36 in both app user and non-app user groups
Assessment of patient satisfaction with treatment	Month 3, 6, 12, 24, 36	Assessment of patient satisfaction with treatment (VAS 0-10, where 0 is completely dissatisfied, and 10 is completely satisfied) at M3, M6, M12, M24, and M36 in both app user and non-app user groups
Dose intensity	Month 3, 6, 12, 24, 36	Dose intensity (% of missed doses as assessed by the patient, except for therapy suspension due to AE) at M3, M6, M12, M24, and M36 in both app user and non-app user groups
Number of patients with adverse events (AE)	Month 3, 6, 12, 24, 36	The percentage (%) of patients with AE (cumulative and depending on the severity) at M3, M6, M12, M24, and M36 in both app user and non-app user groups
Number of patients with dose reduction and/or discontinuation of ribociclib therapy due to progression, death for breast cancer, death from another cause, other AE	Month 3, 6, 12, 24, 36	The percentage (%) of patients with dose reduction and/or discontinuation of ribociclib therapy due to progression, death for breast cancer, death from another cause, other AE at M3, M6, M12, M24, and M36 in both app user and non-app user groups
Number of patients by age, education, occupation, TNM (tumor, nodus, metastasis) stage, tumor grade (G), Ki67 level in both app user and non-app user groups	Baseline	Proportion (%) of patients by age, education, occupation, TNM (tumor, nodus, metastasis) stage, tumor grade (G), Ki67 level in both app user and non-app user groups