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NCT Number: 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

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Pskov, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ribociclib

Drug

CDK4/6 inhibitor

letrozole

Drug

Aromatase inhibitor

Anastrozole

Drug

Aromatase inhibitor

Primary outcomes

  1. Number (%) of patients who remain on treatment with ribociclib + AI over the 12 months period

    Time frame: 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 outcomes

  1. Number of sessions using the web application per month

    Time frame: Month 1 - Month 36

    To describe the rate of the web application usage in the group of patients who use the web application.

  2. Total duration of sessions (in minutes) per month

    Time frame: Month 1 - Month 36

    To describe the rate of the web application usage in the group of patients who use the web application.

  3. Number of questions to the chatbot per month

    Time frame: Month 1 - Month 36

    To describe the rate of the web application usage in the group of patients who use the web application.

  4. 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 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

  5. Evaluation of oncologist satisfaction with the application according to a 0-10 VAS

    Time frame: 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

  6. Number of patients in each response category according to the questionnaire on quality of life

    Time frame: 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

  7. VAS score according to the questionnaire on quality of life

    Time frame: 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

  8. Assessment of patient satisfaction with treatment

    Time frame: 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

  9. Dose intensity

    Time frame: 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

  10. Number of patients with adverse events (AE)

    Time frame: 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

  11. 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

    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

  12. 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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Acronym: IMPULSE

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 1, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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