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

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: Breast Cancer

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

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 Classified According to Treatment Pattern	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.	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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

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): July 22, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: advanced breast cancer; metastatic breast cancer; HR+/HER2-
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• 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.