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Completed

NCT Number: NCT07086196

A Study of Real-World Outcomes of Ribociclib in First-Line Treatment for Metastatic HR+/HER2- Breast Cancer

The main aim of this study was to describe the profile of hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (mBC) patients who received first-line (1L) current treatment options with ribociclib in the United States (US) clinical practice.

This study used administrative claims data. De-identified patient-level data of adult patients with HR+/HER2- mBC who initiated 1L treatment with a cyclin dependant kinase 4/6 inhibitor (CDK4/6i) i.e., ribociclib from the Komodo Health Solutions Research Database (KRD; data from 1 January 2016 to 30 June 2023) was used. Data included medical and pharmacy claims for insured patients, which had already been collected (i.e., secondary use of data).

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Key information

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

  • Had 1 or more paid pharmacy claims for ribociclib with the first claim for the CDK4/6i observed between 26 February 2018 and 31 December 2022 (i.e., during the index period)
  • With the index CDK4/6i used in combination with an endocrine-based therapy, that is an aromatase inhibitor (i.e., letrozole, anastrozole, or exemestane), or fulvestrant, as 1L treatment for mBC
  • With the endocrine therapy (ET) initiated within 60 days of the first paid pharmacy claim of the index CDK4/6i; ET may have been initiated no earlier than 60 days prior to the index date (expected window for insurance approval of the CDK4/6i as 1L treatment for mBC in a real-world setting)
  • Adult who was 18 years of age or older as of the index date
  • Had 2 or more medical service claims with a code for breast cancer (BC) separated by 30 days or more, and 1 or more claims with a code for BC prior to the index date
  • Had 2 or more medical service claims with a code for a secondary neoplasm separated by 30 days or more, with the first code for a secondary neoplasm occurring not earlier than 30 days from the first diagnosis for BC, and 1 or more claims with a code for a secondary neoplasm prior to the index date
  • Had continuous health plan enrollment for 12 months or more prior to and 1 month or more after the index date

Exclusion criteria

  • Patients who did not meet the inclusion criteria
  • Had a diagnosis for other primary cancers (other than BC) before the first diagnosis for secondary neoplasm
  • Had prior treatments for BC (i.e., chemotherapy, targeted therapy, ET [except ≤60 days prior to index date], or immunotherapy) during the 12-month washout period (relapsed/progressed ≤12 months prior to index date)
  • Had prior surgical procedure for BC during the 12-month washout period (relapsed/progressed ≤12 months prior to index date)
  • Had evidence of participation in a clinical trial prior to or at the index date (International Classification of Disease, 10th Edition, Clinical Modification [ICD-10-CM]: Z00.6)

Treatment and study plan

Primary outcomes

  1. Number Patients by Demographic Category

    Time frame: Baseline

    Demographics included:

    • Age (≥ 65 years, ≥ 75 years)
    • Gender
    • Race
    • Index year (year of the first paid pharmacy claim for ribociclib)
  2. Number of Patients by Clinical Characteristic Category

    Time frame: Baseline

    Clinical characteristic categories included:

    • Menopausal status
    • Comorbidity
    • Metastatic site
    • Eastern Cooperative Oncology Group (ECOG) performance score less than 2

    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: National Cancer Institute (NCI) Comorbidity Index Score

    Time frame: Baseline

    The NCI comorbidity index is a tool used to measure the risk of non-cancer deaths for cancer patients based on the presence and severity of other health conditions. It includes 14 conditions identified using administrative data diagnosis and procedure codes. The index excludes solid tumors, leukemias, and lymphomas as comorbid conditions. Each condition is assigned a score based on how serious it is and patient scores are summed to give a final overall score. A high score indicates a higher burden of comorbid conditions and possible higher risk of death.

  4. Clinical Characteristic: Number of Metastatic Sites

    Time frame: Baseline

  5. Treatment Characteristic: Number of Patients by Type of Treatment Received While on 1L mBC Treatment

    Time frame: Up to approximately 3 years and 4 months

    Treatments included:

    • Endocrine therapy partner (AI, Fulvestrant, or AI and Fulvestrant)
    • Gonadotropin-releasing hormone (GNRH)
    • Cytochrome P450, family 3, subfamily A (CYP3A) inhibitors and inducers
    • P-inhibitors and inducers
    • Medications potentially associated with an increased risk of torsade de pointes
  6. Treatment Characteristic: Time from mBC diagnosis to 1L Initiation

    Time frame: Baseline

  7. Treatment Characteristic: Duration of Follow-up From 1L Initiation

    Time frame: Up to approximately 3 years and 4 months

  8. Treatment Characteristic: Duration of 1L mBC Treatment

    Time frame: Up to approximately 3 years and 4 months

Secondary outcomes

  1. Number of Patients by Tolerability-related Medical Events Experienced While on 1L Treatment With Ribociclib

    Time frame: Up to approximately 3 years and 4 months

    Medical events were assessed among patients who did not have the selected condition during the baseline period and were described based on the presence of 2 or more medical claims on distinct dates.

  2. Number of Patients by Cardiovascular-related Medical Events Experienced While on 1L Treatment With Ribociclib

    Time frame: Up to approximately 3 years and 4 months

    Medical events were assessed among patients who did not have the selected condition during the baseline period and were described based on the presence of 2 or more medical claims on distinct dates.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Retrospective Analysis of Real-World Outcomes of Ribociclib in First-Line Treatment for Metastatic HR+/HER2- Breast Cancer

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 25, 2025
Registry last updated
Jul 25, 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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