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

Completed

• Conditions: Breast Cancer

• Registration Number: NCT05770713
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-12
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28
• Study First Submitted: 2023-03-05
• Study First Submitted QC: 2023-03-05
• Study First Posted: 2023-03-15
• Status Verified: 2024-02
• Results First Submitted: 2024-02-07
• Results First Submitted QC: 2024-02-07
• Last Update Submitted: 2024-02-07
• Results First Posted: 2024-07-22
• Last Update Posted: 2024-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants Classified According to Treatment Pattern	From date of ABC/MBC diagnosis until date of death, date of last follow-up or the end of the study period, whichever came first (maximum follow-up of 67.6 months); available data evaluated over approximately 4.5 months of this retrospective study	Number of participants according to the treatment patterns for first line, second line and third line were reported in this outcome measure. CDK4/6i included abemaciclib, palbociclib and ribociclib. Endocrine therapy (ET) included anastrozole, exemestane, fulvestrant, letrozole and tamoxifen. Chemotherapy included capecitabine, cisplatin, cyclophosphamide, docetaxel, doxorubicin, eribulin, gemcitabine and paclitaxel.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Classified According to Type of Treatment Before Introduction of CDK4/6 Inhibitor	From date of ABC/MBC diagnosis until introduction of CDK 4/6 inhibitor(anytime between Jan 2016 to May 2016, approximately 4 months); available data evaluated over approximately 4.5 months of this retrospective study
Number of Participants Classified According to Type of Treatment After Introduction of CDK4/6 Inhibitor	From date of introduction of CDK4/6 inhibitor until date of death, date of last follow-up or the end of the study period, whichever came first (approximately 33 months); available data evaluated over approximately 4.5 months of this retrospective study

Trial Locations

Locations (1)

Pfizer Canada; 🇨🇦 Kirkland, Quebec, Canada