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NCT05770713 Clinical Trial

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

Breast Cancer Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05770713
Other study ID # A5481178
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 12, 2022
Est. completion date February 28, 2023

Study information
Verified date April 2023
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date February 28, 2023
Est. primary completion date February 28, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Canada Pfizer Canada Kirkland Quebec

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants With HR+/HER2-ABC/MBC receiving palbociclib combination treatment 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 Number of patients with pre-CDK4/6i treatment patterns and sequencing in ABC/MBC To explore treatment patterns and sequencing before the introduction of CDK4/6 inhibitor. 01 Jan 2016 through 01 Oct 2021
Secondary Number of patients with post-CDK4/6i treatment patterns and sequencing in ABC/MBC To explore treatment patterns and sequencing after introduction of CDK4/6 inhibitors 01 Jan 2016 through 01 Oct 2021
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