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Completed

NCT Number: NCT05141240

A Real-world Analysis of Concomitant Medication Use Among Metastatic Breast Cancer Patients Treated With CDK4/6 Inhibitors

This is a retrospective cohort study to assess the real-world analysis of concomitant medication use among metastatic breast cancer patients treated with CDK4/6 inhibitors utilizing the US Optum research administrative claims database.

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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–85 year

Sex eligibility

Female

Study type

Observational

Primary location

Novartis Investigational site

East Hanover, New Jersey, 07936, United States

About this study

This is a retrospective cohort study utilizing the US Optum research administrative claims database. Adult female patients who had HR+/HER2- mBC were identified and included in the study. These patients were stratified into three cohorts based on the first CDK4/6i received (ribociclib, palbociclib, or abemaciclib).

  • Study period: Period during which all relevant medical and pharmacy information in the database was retrieved
  • Index event identification period: time frame during which index treatment was identified
  • First CDK4/6i: the date on which patients initiated their first treatment after being diagnosed with HR+/HER2- mBC; this date was considered as the index date
  • Baseline period: Time frame during which patient characteristics, prior mBC treatments, and concomitant treatments received by CDK4/6i-naïve patients were evaluated
  • Follow-up period: time frame on and after the index date during which patients' treatments and dosing patterns were observed

Establishment of baseline period Health plan enrollment in the three months prior to the index treatment was included in the baseline period. Patient demographics, clinical characteristics, National Cancer Institute (NCI) comorbidity index, concomitant medication use that can potentially lead to a DDI, and other BC treatments prior to the index treatment were evaluated during this period.

Establishment of follow-up period Patients were observed for ≥3 months starting from the index date until the end of the study period or continuous enrollment or until the time when patients switched to another therapy (including another CDK4/6i), whichever came first. Dosing patterns for CDK4/6i were evaluated in the follow-up period. Analyses were conducted at key time points of 3, 6, and 12 months

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Treated with CDK4/6i from 2015-02-01 to 2019-06-30
  • ≥2 claims with a BC diagnosis recorded ≥30 days apart from the index date
  • ≥2 claims with an mBC diagnosis, with a time interval between the first BC diagnosis date and the first mBC diagnosis date no longer than 30 days
  • Female patients aged ≥18 years
  • Continuous health plan enrollment for ≥3 months prior to the index date and ≥3 months post-index date

Exclusion criteria

  • None

Treatment and study plan

Ribiciclib

Drug

Participants who initiated CDK4/6i therapy

Palbociclib

Drug

Participants who initiated CDK4/6i therapy

Abemaciclib

Drug

Participants who initiated CDK4/6i therapy

Primary outcomes

  1. Number of participants with a prescription fill of ribociclib, palbociclib, or abemaciclib

    Time frame: Index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time)

    Distribution of patients with a prescription fill of ribociclib, palbociclib, or abemaciclib at index treatment date will be present by frequency among all patients treated with CDK4/6

  2. Number of participants who took concomitant medications in baseline period, by drug name

    Time frame: Baseline period (3 months)

    Number of patients taking a concomitant medication/s during baseline period that can potentially lead to a drug-drug interactions (DDI) with a CDK4/6 inhibitor use with each CDK4/6 inhibitor in the follow-up period.

  3. Number of participants who took concomitant medications in follow-up period, by drug name

    Time frame: From index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time) to the end of follow-up period (12 months post index date)

    Number of patients taking a concomitant medication/s during baseline period that can potentially lead to a drug-drug interactions (DDI) with a CDK4/6 inhibitor use with each CDK4/6 inhibitor in the follow-up period.

  4. Number of participants with no use of concomitant medications

    Time frame: Baseline period (3 months)

    Adherence to concomitant medications during the baseline period was reported

  5. Number of participants with proportion of days covered (PDC) >80%

    Time frame: Baseline period (3 months)

    Adherence to concomitant medication during the baseline period will be assessed using the proportion of days covered (PDC):

    PDC = total days of filled or refilled concomitant Rx in baseline period / total number of days in baseline period

  6. Number of participants with proportion of days covered (PDC) ≤80%

    Time frame: Baseline period (3 months)

    Adherence to concomitant medication during the baseline period will be assessed using the proportion of days covered (PDC):

    PDC = total days of filled or refilled concomitant Rx in baseline period / total number of days in baseline period

  7. Number of other breast cancer medications used

    Time frame: Baseline period (3 months)

    Number of other breast cancer medications used in baseline period, by drug class (HR+/Endocrine, Chemotherapy, Other treatments), for breast cancer regimens was reported

Secondary outcomes

  1. Mean starting dose for each CDK4/6

    Time frame: From index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time) to the end of follow-up period (12 months post index date)

    Distribution of starting dose and mean starting dose for each CDK4/6 was reported to describe dosing and treatment patterns associated with ribociclib, palbociclib, and abemaciclib patients

  2. Number of participants who had any dose change (increase, decrease)

    Time frame: From index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time) to the end of follow-up period (12 months post index date)

    Number of patients with change in dose by each CDK4/6 inhibitor (ribociclib, palbociclib, and abemaciclib) in the follow-up period was reported

  3. Number of participants who had a dose increase

    Time frame: From index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time) to the end of follow-up period (12 months post index date)

    Number of patients with change in dose by each CDK4/6 inhibitor (ribociclib, palbociclib, and abemaciclib) in the follow-up period was reported

  4. Number of participants who had a dose decrease

    Time frame: From index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time) to the end of follow-up period (12 months post index date)

    Number of patients with change in dose by each CDK4/6 inhibitor (ribociclib, palbociclib, and abemaciclib) in the follow-up period was reported

  5. Number of participants discontinuing each CDK4/6i (ribociclib, palbociclib, or abemaciclib)

    Time frame: From index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time) to the end of follow-up period (12 months post index date)

    Rate of discontinuation of ribociclib, palbociclib, or abemaciclib in the follow-up period was reported

  6. Median duration of treatment (in months) by each CDK4/6i (ribociclib, palbociclib, or abemaciclib)

    Time frame: From index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time) to the end of follow-up period (12 months post index date)

    Duration of treatment with ribociclib, palbociclib, or abemaciclib, defined as discontinuation of each index CDK 4/6 treatment during the follow-up period was reported

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 2, 2021
Registry last updated
Dec 16, 2021

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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