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

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05141240
• Other study ID #: CLEE011AUS64
• Status: Completed
• Start date: April 15, 2020
• Est. completion date: June 15, 2020

Study information

• Verified date: December 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4650
• Est. completion date: June 15, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Ribiciclib
Participants who initiated CDK4/6i therapy
• Palbociclib
Participants who initiated CDK4/6i therapy
• Abemaciclib
Participants who initiated CDK4/6i therapy

Locations

Country	Name	City	State
United States	Novartis Investigational site	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with a prescription fill of ribociclib, palbociclib, or abemaciclib	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	Index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time)
Primary	Number of participants who took concomitant medications in baseline period, by drug name	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.	Baseline period (3 months)
Primary	Number of participants who took concomitant medications in follow-up period, by drug name	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.	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)
Primary	Number of participants with no use of concomitant medications	Adherence to concomitant medications during the baseline period was reported	Baseline period (3 months)
Primary	Number of participants with proportion of days covered (PDC) >80%	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	Baseline period (3 months)
Primary	Number of participants with proportion of days covered (PDC) =80%	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	Baseline period (3 months)
Primary	Number of other breast cancer medications used	Number of other breast cancer medications used in baseline period, by drug class (HR+/Endocrine, Chemotherapy, Other treatments), for breast cancer regimens was reported	Baseline period (3 months)
Secondary	Mean starting dose for each CDK4/6	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	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)
Secondary	Number of participants who had any dose change (increase, decrease)	Number of patients with change in dose by each CDK4/6 inhibitor (ribociclib, palbociclib, and abemaciclib) in the follow-up period was reported	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)
Secondary	Number of participants who had a dose increase	Number of patients with change in dose by each CDK4/6 inhibitor (ribociclib, palbociclib, and abemaciclib) in the follow-up period was reported	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)
Secondary	Number of participants who had a dose decrease	Number of patients with change in dose by each CDK4/6 inhibitor (ribociclib, palbociclib, and abemaciclib) in the follow-up period was reported	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)
Secondary	Number of participants discontinuing each CDK4/6i (ribociclib, palbociclib, or abemaciclib)	Rate of discontinuation of ribociclib, palbociclib, or abemaciclib in the follow-up period was reported	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)
Secondary	Median duration of treatment (in months) by each CDK4/6i (ribociclib, palbociclib, or abemaciclib)	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	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)

External Links

•   Results for CLEE011AUS64 from the Novartis Clinical Trials Website