A Real-life Study to Learn About the Use and Effects of the CDK4/6 Inhibitors in Canadian Patients With Breast Cancer.

April 20, 2023 updated by: Pfizer

Treatment Patterns And Clinical Outcomes Among Patients Receiving CDK4/6 Inhibitors Combinations For HR+/HER2- Advanced/Metastatic Breast Cancer In A Canadian Real World Setting

CDK4/6 inhibitors are approved medicines indicated for the treatment of a kind of advanced/metastatic breast cancer, called hormone receptors positive (HR+)/ Human epidermal growth factor receptor 2 negative (HER2-) disease. They are given orally in combination with hormonal therapies.

The purpose of this study is to better understand how the CDK4/6 inhibitors combinations are used in real-life conditions and their clinical impact for the treatment of Canadian patients affected by (HR+)/ (HER2-) advanced breast cancer (ABC) or metastatic breast cancer (MBC).

Female patients aged 18 years old or more presenting the following conditions will be selected for the study:

  • HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease
  • Diagnosis of ABC/MBC between 01 January 2016 and 01 July 2021
  • Treatment with CDK4/6 inhibitor

Information will be collected from one single Canadian institution, on each selected real-life patient treated with CDK4/6 inhibitors.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Kirkland, Quebec, Canada, H9J2M5
        • Pfizer Canada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Female patients diagnosed with HR+/HER2- ABC/MBC who received a CDK4/6 inhibitor at Sinai Health, Canada during the study period.

Description

Inclusion Criteria:

  • HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease
  • Diagnosed with ABC/MBC between 01 Jan 2016 and 01 July 2021
  • Treatment with CDK4/6 inhibitor

Exclusion Criteria:

  • Patient does not have ABC/MBC
  • Patient has indicated HR- or HER2+ status
  • Patient received a CDK4/6i as part of a clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Female patients with HR+/HER2- ABC/MBC who received a CDK4/6i based therapy for their ABC/MBC.
Female patients who received an oral treatment of CDK4/6i based therapy for their ABC/MBC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With HR+/HER2-ABC/MBC receiving palbociclib combination treatment
Time Frame: 01 Jan 2016 through 01 Oct 2021
To characterize real world treatment patterns among patients with HR+/HER2-ABC/MBC receiving palbociclib combination treatment (non-steroidal AI (NSAI) [letrozole or anastrozole], or fulvestrant).
01 Jan 2016 through 01 Oct 2021

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with pre-CDK4/6i treatment patterns and sequencing in ABC/MBC
Time Frame: 01 Jan 2016 through 01 Oct 2021
To explore treatment patterns and sequencing before the introduction of CDK4/6 inhibitor.
01 Jan 2016 through 01 Oct 2021
Number of patients with post-CDK4/6i treatment patterns and sequencing in ABC/MBC
Time Frame: 01 Jan 2016 through 01 Oct 2021
To explore treatment patterns and sequencing after introduction of CDK4/6 inhibitors
01 Jan 2016 through 01 Oct 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2022

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

March 5, 2023

First Submitted That Met QC Criteria

March 5, 2023

First Posted (Actual)

March 15, 2023

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

April 20, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5481178

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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