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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

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

External Links

•   To obtain contact information for a study center near you, click here.