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Completed

NCT Number: NCT07148505

A Study of Real-world Outcomes Among Patients Treated With Ribociclib

The main aim of the study was to evaluate the real-world tolerability and safety of ribociclib as a first-line (1L) treatment among adults with hormone receptor-positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) metastatic breast cancer (mBC).

This study used data from the Flatiron Health Research Database (FHRD). The FHRD is a longitudinal database derived from electronic health records (EHRs) and other real-world data (RWD) sources from cancer care providers across the United States. The dataset generated for this study included de-identified patient-level data for eligible individuals between 1 January 2015 up to the data cutoff date, 30 November 2022.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with mBC on or after 1 January 2015.
  • Had HR+/HER2- test results.
  • Received ribociclib and endocrine therapy in 1L treatment.
  • Patients had a gap of 90 days or less between mBC diagnosis date and the first structured EHR activity (e.g., lab tests and prescriptions) after metastatic diagnosis date.

Exclusion criteria

None identified.

Treatment and study plan

Primary outcomes

  1. Number of Patients by Type of Real-world Adverse Event (AE) of Interest During 1L Treatment

    Time frame: Up to approximately 5 years and 5 months

  2. Number of Patients by Real-world AE of Interest at Baseline

    Time frame: Baseline

  3. Number of Patients by Type of Real-world AE of Interest During 1L Treatment Among Those Without the Specific Real-world AE at Baseline

    Time frame: Up to approximately 5 years and 5 months

Secondary outcomes

  1. Number of Patients by Demographic Category

    Time frame: Baseline

    Demographics included:

    • Age at start of 1L treatment (18-64, 65 years or older)
    • Gender
    • Race
    • Ethnicity

  2. Number of Patients by Clinical Characteristic Category

    Time frame: Baseline

    Clinical characteristics included:

    • Type of medical practice (academic, community or both)
    • Geographic region
    • Type of health plan
    • Stage of cancer at initial diagnosis
    • Year of metastatic cancer diagnosis
    • Eastern Cooperative Oncology Group (ECOG) performance score
    • Received chemotherapy prior to ribociclib treatment initiation
    • Menopausal status

    ECOG performance score measures a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability. Scores range from 0 (fully active, able to carry out all pre-disease performance without restriction) to 5 (deceased).

  3. Clinical Characteristic: Body Mass Index (BMI)

    Time frame: Baseline

  4. Clinical Characteristic: Time Between Initial Diagnosis and Metastatic Diagnosis

    Time frame: Baseline

  5. Clinical Characteristic: Time Between Metastatic Diagnosis and Initiation of 1L Treatment

    Time frame: Baseline

  6. Clinical Characteristic: Duration of Follow-up

    Time frame: Up to approximately 5 years and 5 months

  7. Clinical Characteristic: Number of Patients by Patient Disposition at Data Cutoff

    Time frame: Up to approximately 5 years and 5 months

    Patient disposition included patients who died and discontinued treatment early.

  8. Number of Patients by Year of Treatment Initiation for Each Line of Treatment

    Time frame: Up to approximately 5 years and 5 months

    Lines of treatment included 1L, second-line (2L), and third-line (3L).

  9. Duration of Each Line of Treatment

    Time frame: Up to approximately 5 years and 5 months

    Lines of treatment included 1L, 2L, and 3L.

  10. Number of Patients Still on 1L Treatment at Last EHR Activity

    Time frame: Up to approximately 5 years and 5 months

  11. Number of Patients Still on 2L Treatment at Last EHR Activity

    Time frame: Up to approximately 5 years and 5 months

  12. Number of Patients Still on 3L Treatment at Last EHR Activity

    Time frame: Up to approximately 5 years and 5 months

  13. Number of Patients by Type of ET Partner During 1L Treatment

    Time frame: Up to approximately 5 years and 5 months

  14. Number of Patients by Treatment Category During Each Line of Treatment

    Time frame: Up to approximately 5 years and 5 months

    Lines of treatment included 1L, 2L, and 3L.

    Treatment categories included:

    • Cyclin dependent kinase 4/6 (CDK4/6) inhibitor based regimen
    • Chemotherapy based regimen
    • Clinical study drug
    • ET monotherapy
    • mTor based regimen
    • PI3K based regimen

  15. Number of Patients by Type of CDK4/6 Inhibitor Based Treatment During Each Line of Treatment

    Time frame: Up to approximately 5 years and 5 months

    Lines of treatment included 1L, 2L, and 3L.

    CDK4/6 inhibitor-based treatments included:

    • Ribociclib
    • Abemaciclib
    • Palbociclib

  16. Number of Patients by Total Number of Ribocicilib Dose Reduction Episodes During 1L Treatment

    Time frame: Up to approximately 5 years and 5 months

  17. Number of Patients by Ribociclib Dose at Each Dose Reduction Episode During 1L Treatment

    Time frame: Up to approximately 5 years and 5 months

  18. Number of Patients by Ribociclib Dosing Schedule at Each Dose Reduction Episode During 1L Treatment

    Time frame: Up to approximately 5 years and 5 months

  19. Number of Patients by Status of Oral Therapy at the End of Each Dose Reduction Episode During 1L Treatment

    Time frame: Up to approximately 5 years and 5 months

    Status included continuing, discontinued, dose change, held, not documented, and unknown, patient sent to hospice.

  20. Number of Patients by Reason for Change in Ribociclib Dose During 1L Treatment

    Time frame: Up to approximately 5 years and 5 months

  21. Number of Patients by Reason for Stopping Ribociclib 1L Treatment

    Time frame: Up to approximately 5 years and 5 months

  22. Number of Patients by Type of Real-world Adverse Event (AE) During 1L Treatment

    Time frame: Up to approximately 5 years and 5 months

  23. Number of Patients by Action Following or in Response to Real-world AE During 1L Treatment

    Time frame: Up to approximately 5 years and 5 months

    Actions included:

    • Hospitalization
    • Treatment for AE
    • Therapy discontinuation
    • Therapy dose or schedule change
    • Therapy hold

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Assessment of Real-world Outcomes Among Patients Treated With Kisqali (Ribociclib)

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 29, 2025
Registry last updated
Aug 29, 2025

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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