NCT06003114

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
472

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 6, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2024

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

August 10, 2023

Last Update Submit

May 14, 2024

Conditions

Breast Cancer

Keywords

Metastatic breast cancer (MBC)Human epidermal growth factor receptor 2 negative (HER2-)Hormone receptor positive (HR+)First lineReal world

Outcome Measures

Primary Outcomes (1)

  • Estimate the median Duration of Treatment (DoT)

    Time index of approximately 01 Jan 2016 to 31 March 2022

Secondary Outcomes (5)

  • 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

Study Arms (1)

First-line patients on Palbociclib

Participants taking oral palbociclib as prescribed in first-line treatment

Drug: Palbociclib

Interventions

PalbociclibDRUG

Participants taking oral palbociclib as prescribed in first-line treatment.

Also known as: Ibrance
First-line patients on Palbociclib

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alberta Health Services

Edmonton, Alberta, T5J 3E4, Canada

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

palbociclib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2023

First Posted

August 21, 2023

Study Start

October 6, 2023

Primary Completion

February 22, 2024

Study Completion

February 22, 2024

Last Updated

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

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.

Locations

CA(1)