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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06003114
• Other study ID #: A5481183
• Secondary ID: PALCAN
• Status: Completed
• Start date: October 6, 2023
• Est. completion date: February 22, 2024

Study information

• Verified date: May 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 472
• Est. completion date: February 22, 2024
• Est. primary completion date: February 22, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Palbociclib
Participants taking oral palbociclib as prescribed in first-line treatment.

Locations

Country	Name	City	State
Canada	Alberta Health Services	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimate the median Duration of Treatment (DoT)		Time index of approximately 01 Jan 2016 to 31 March 2022
Secondary	Number of patients with treatment discontinuation at one-year intervals		Time index of approximately 01 Jan 2016 to 31 March 2022
Secondary	Number of patients starting at initial dose		Time index of approximately 01 Jan 2016 to 31 March 2022
Secondary	Time to chemotherapy		Time index of approximately 01 Jan 2016 to 31 March 2022
Secondary	Clinical Characteristics of Patients		Time index of approximately 01 Jan 2016 to 31 March 2022
Secondary	Demographical Characteristics of Patients		Time index of approximately 01 Jan 2016 to 31 March 2022

External Links

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