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OpenTrials
Completed

NCT Number: NCT07512063

A Study of Real-World Treatment Patterns and Outcomes Among HR+/HER2- Metastatic Breast Cancer Patients Treated With First-Line CDK4/6 Inhibitors

The aim of this study was to evaluate patient profiles, treatment patterns, and outcomes of hormone receptor positive (HR+)/human epidermal growth factor receptor-2 negative (HER2-) metastatic breast cancer (mBC) patients treated with a 1L cyclin dependent kinase 4/6 inhibitor (CDK4/6i) in the real-world setting.

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Key information

Age range

18 year and older

Sex eligibility

Female

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

  • A diagnosis of mBC based on at least two diagnoses of breast cancer (International Classification of Diseases, 10th Revision, Clinical Modification [ICD-10-CM] code C50.xxx) along with a diagnosis of secondary malignant neoplasm (ICD-10-CM codes C77.xxx - C80.xxx except C79.8 or C79.81, reporting of a metastatic site by curation), in the period prior to or on the index date.
  • Patients with HR+/HER2- status.
  • Use of either ribociclib, palbociclib, or abemaciclib in 1L treatment for mBC.
  • Continuous care at the contributing practices. Patients with a minimum of two visits up to and including the index date.

Exclusion criteria

  • Use of any prior CDK4/6i before the index date.
  • Prior 1L treatment, other than CDK4/6i, in mBC including treatment with endocrine therapy (ET) either with tamoxifen, aromatase inhibitors (AI; anastrozole, exemestane, or letrozole) or fulvestrant. For it to be considered 1L in mBC, the diagnosis of mBC must have preceded treatment initiation, or was indicated so in unstructured data.
  • Diagnosis of cancer other than breast cancer and/or mBC on or prior to the index.
  • Evidence of participation in a clinical trial at any time during the study observation period.

Treatment and study plan

Primary outcomes

  1. Number and Percentage of Patients Treated With 1L Ribociclib by Demographic Category

    Time frame: Baseline

    Demographics included:

    • Age group
    • Sex
    • Race
    • Ethnicity
    • Geographical region
    • Payer type
    • Year of 1L treatment initiation
    • De novo or recurrent mBC
  2. Age at 1L Ribociclib Treatment Initiation

    Time frame: Baseline

  3. Among 1L Ribociclib Patients, Age at mBC Diagnosis

    Time frame: Baseline

  4. Among 1L Ribociclib Patients, Age at Initial BC Diagnosis

    Time frame: Baseline

  5. Interval Between mBC Diagnosis and 1L Ribociclib Initiation

    Time frame: Baseline

  6. Number and Percentage of 1L Ribociclib Patients by Clinical Characteristic Category

    Time frame: Baseline

    Clinical characteristics included:

    • Menopausal status
    • Eastern Cooperative Oncology Group (ECOG) performance status
    • Stage at initial breast cancer (BC) diagnosis
    • Comorbidities
    • QT prolongation diagnosis (yes/no)
    • Sites of metastasis
  7. Among 1L Ribociclib Patients, Body Mass Index (BMI)

    Time frame: Baseline

  8. Follow-up Time From 1L Ribociclib Treatment Initiation

    Time frame: Up to approximately 7 years and 6 months

  9. Among 1L Ribociclib Patients, Number of Metastatic Sites per Patient at Baseline

    Time frame: Baseline

  10. Among 1L Ribociclib Patients, Number of Metastatic Sites per Patient any Time During Study

    Time frame: Up to approximately 7 years and 6 months

  11. Number and Percentage of 1L Ribociclib Patients by Sites of Metastasis During Follow-up

    Time frame: Up to approximately 7 years and 6 months

  12. Number and Percentage of 1L Ribociclib Patients by Type of Medical Procedures Received

    Time frame: Baseline

  13. Number and Percentage of 1L Ribociclib Patients With ESR1 Mutation at Baseline

    Time frame: Baseline

  14. Number and Percentage of 1L Ribociclib Patients With ESR1 Mutation any Time During Study

    Time frame: Up to approximately 7 years and 6 months

  15. Among 1L Ribociclib Patients, Red Blood Cell (RBC) Count

    Time frame: Baseline

  16. Among 1L Ribociclib Patients, Hemoglobin Level

    Time frame: Baseline

  17. Among 1L Ribociclib Patients, Hematocrit Level

    Time frame: Baseline

  18. Among 1L Ribociclib Patients, White Blood Cell Count

    Time frame: Baseline

  19. Among 1L Ribociclib Patients, Platelet Count

    Time frame: Baseline

  20. Number and Percentage of 1L Ribociclib Patients With Neutropenia

    Time frame: Baseline

  21. Among 1L Ribociclib Patients, Serum Creatinine Level

    Time frame: Baseline

  22. Among 1L Ribociclib Patients, Aspartate Aminotransferase (AST) Level

    Time frame: Baseline

  23. Among 1L Ribociclib Patients, Alanine Aminotransferase (ALT) Level

    Time frame: Baseline

  24. Among 1L Ribociclib Patients, Alkaline Phosphatase (ALP) Level

    Time frame: Baseline

  25. Among 1L Ribociclib Patients, Bilirubin Level

    Time frame: Baseline

  26. Number and Percentage of 1L Ribociclib Patients by Type of Other Medications in 1L Treatment

    Time frame: Baseline

  27. Interval Between Treatment Initiation and Ribociclib Initiation

    Time frame: Baseline

  28. Number and Percentage of Patients by Type of Treatment Received per Line of Treatment

    Time frame: Up to approximately 7 years and 6 months

Secondary outcomes

  1. Number and Percentage of 1L Ribociclib Patients by Type of First Dose Adjustment

    Time frame: Up to approximately 7 years and 6 months

    Dose adjustments included up titration and down titration.

  2. Among 1L Ribociclib Patients, Number of Total Dose Adjustments

    Time frame: Up to approximately 7 years and 6 months

  3. Number and Percentage of 1L Ribociclib Patients by Starting Dose of Ribociclib

    Time frame: Baseline

  4. Relative Dose Intensity (RDI) of Ribociclib

    Time frame: Up to approximately 7 years and 6 months

    RDI was calculated by dividing the actual average daily dose by the recommended daily dose.

  5. Ribociclib Dose at First Dose Adjustment

    Time frame: Up to approximately 7 years and 6 months

  6. Among 1L Ribociclib Patients, Time to First Dose Adjustment

    Time frame: Up to approximately 7 years and 6 months

  7. Number and Percentage of Patients by Ribociclib Dosage Received per Dose Adjustment

    Time frame: Up to approximately 7 years and 6 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Real World Treatment Patterns and Outcomes in HR+, HER2- Metastatic Breast Cancer Patients Treated With CDK 4/6 Inhibition in the First Line (1L) Setting

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 6, 2026
Registry last updated
Apr 13, 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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