Clinical trial NCT06003114: A Study to Understand the Use of Palbociclib in Canadian Patients With Breast Cancer That Has Spread to Other Organs
Official title: Real-World Utilization of Palbociclib as 1L Treatment in Canadian HR+/HER2-women Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Metastatic breast cancer (MBC)
Human epidermal growth factor receptor 2 negative (HER2-)
Hormone receptor positive (HR+)
First line
Real world
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-08-21
Enrollment: 472
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Treatment of Canadian women patients on palbociclib with HR+/HER2- metastatic breast cancer

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Estimate the median Duration of Treatment (DoT)
timeFrame: Time index of approximately 01 Jan 2016 to 31 March 2022
Secondary outcomes:
measure: Number of patients with treatment discontinuation at one-year intervals
timeFrame: Time index of approximately 01 Jan 2016 to 31 March 2022
measure: Number of patients starting at initial dose
timeFrame: Time index of approximately 01 Jan 2016 to 31 March 2022
measure: Time to chemotherapy
timeFrame: Time index of approximately 01 Jan 2016 to 31 March 2022
measure: Clinical Characteristics of Patients
timeFrame: Time index of approximately 01 Jan 2016 to 31 March 2022
measure: Demographical Characteristics of Patients
timeFrame: Time index of approximately 01 Jan 2016 to 31 March 2022
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Alberta Health Services
state: Alberta
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: