A Study to Understand the Use of Palbociclib in Canadian Patients With Breast Cancer That Has Spread to Other Organs

Real-World Utilization of Palbociclib as 1L Treatment in Canadian HR+/HER2-women Breast Cancer Patients

The purpose of this real-world study is to understand the use of palbociclib as first treatment for Hormone receptor positive (HR+) and Human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer in Canada (PALCAN).

The real-world study is not a research study. It involves real patients who receive medicines prescribed by their doctors in the real world. Metastatic breast cancer is the type which has spread from breast to other organs.

HR positive stands for Hormone-receptor cells that have a protein on their surface that binds to one of 2 types of hormones. They are estrogen or progesterone. Both these hormones help cancer cells grow.

HER2 negative describes cells that have a small amount or none of a protein called HER2 on their surface. In normal cells, HER2 helps control cell growth. Cancer cells that are HER2 negative may grow more slowly and are less likely to come back or spread to other parts of the body.

This study will mainly measure:

- duration of treatment (from start of treatment till end of treatment) among a group of patients taking palbociclib (Ibrance) in combination with hormone therapy as first line treatment for HR+ HER2- metastatic breast cancer.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Palbociclib

• Study Type: Observational
• Enrollment (Actual): 472

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5J 3E4
      • Alberta Health Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Treatment of Canadian women patients on palbociclib with HR+/HER2- metastatic breast cancer

Description

Inclusion Criteria:

• Received at least one cycle of palbociclib as first line therapy for metastatic breast cancer between 01 January 2016 and 31 December 2022
• Histologically confirmed HR+/HER2- metastatic breast cancer
• Minimum of 3 months available follow-up on palbociclib

Exclusion Criteria:

• Received a different CDK4/6 inhibitor before palbociclib in the first line
• Received other systemic therapy, including hormone therapy, 15-60 days prior to initiation of palbociclib
• Invalid or incomplete records (more specifically, complete duration of treatment on palbociclib, endocrine therapy or LHRH)
• Death date recorded on or before the date of index date

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
First-line patients on Palbociclib; Participants taking oral palbociclib as prescribed in first-line treatment	Drug: Palbociclib; Participants taking oral palbociclib as prescribed in first-line treatment.; Other Names: Ibrance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Estimate the median Duration of Treatment (DoT)	Time index of approximately 01 Jan 2016 to 31 March 2022

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients with treatment discontinuation at one-year intervals	Time index of approximately 01 Jan 2016 to 31 March 2022
Number of patients starting at initial dose	Time index of approximately 01 Jan 2016 to 31 March 2022
Time to chemotherapy	Time index of approximately 01 Jan 2016 to 31 March 2022
Clinical Characteristics of Patients	Time index of approximately 01 Jan 2016 to 31 March 2022
Demographical Characteristics of Patients	Time index of approximately 01 Jan 2016 to 31 March 2022

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 6, 2023
• Primary Completion (Actual): February 22, 2024
• Study Completion (Actual): February 22, 2024

Study Registration Dates

• First Submitted: August 10, 2023
• First Submitted That Met QC Criteria: August 18, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: First line; Metastatic breast cancer (MBC); Real world; Hormone receptor positive (HR+); Human epidermal growth factor receptor 2 negative (HER2-)
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Palbociclib
• Other Study ID Numbers: A5481183; PALCAN (Other Identifier: Alias Study Number)

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.