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

Pfizer

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT05770713

A5481178

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

48 participants in 1 patient group

Female patients with HR+/HER2- ABC/MBC who received a CDK4/6i based therapy for their ABC/MBC.

Description:

Female patients who received an oral treatment of CDK4/6i based therapy for their ABC/MBC.