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Recruiting 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

— Observational Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ribociclib, Letrozole, Anastrozole.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Ribociclib
    CDK4/6 inhibitor
  • Drug Letrozole
    Aromatase inhibitor
  • Drug Anastrozole
    Aromatase inhibitor

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Russia · 7 centers
  • Novartis Investigative Site — Pskov
  • Novartis Investigative Site — Moscow
  • Novartis Investigative Site — Saint Petersburg
  • Novartis Investigative Site — Saint Petersburg
  • Novartis Investigative Site — Saint Petersburg
  • Novartis Investigative Site — Sestroretsk
  • Novartis Investigative Site — Ufa

Identifiers

NCT: NCT06905301 · CLEE011O1RU01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗