Clinical trial NCT06905301: 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
Official title: 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 type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
Keywords: Breast cancer
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2025-04-01
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with HR+ HER2- stage II-III breast cancer who have started treatment with ribociclib + AI (± GnRH agonist for premenopausal men and women) will be enrolled in the study

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.


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.

Primary outcomes:
measure: Number (%) of patients who remain on treatment with ribociclib + AI over the 12 months period
timeFrame: 12 months
Secondary outcomes:
measure: Number of sessions using the web application per month
timeFrame: Month 1 - Month 36
measure: Total duration of sessions (in minutes) per month
timeFrame: Month 1 - Month 36
measure: Number of questions to the chatbot per month
timeFrame: Month 1 - Month 36
measure: Evaluation of patient satisfaction with the application on a 0-10 visual analog scale (VAS)
timeFrame: Month 1, 3, 6, 12, 24, 36
measure: Evaluation of oncologist satisfaction with the application according to a 0-10 VAS
timeFrame: Month 1, 3, 6, 12, 24, 36
measure: Number of patients in each response category according to the questionnaire on quality of life
timeFrame: Month 1, 3, 6, 12, 24, 36
measure: VAS score according to the questionnaire on quality of life
timeFrame: Month 1, 3, 6, 12, 24, 36
measure: Assessment of patient satisfaction with treatment
timeFrame: Month 3, 6, 12, 24, 36
measure: Dose intensity
timeFrame: Month 3, 6, 12, 24, 36
measure: Number of patients with adverse events (AE)
timeFrame: Month 3, 6, 12, 24, 36
measure: 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
timeFrame: Month 3, 6, 12, 24, 36
measure: 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
timeFrame: Baseline
Other outcomes:
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