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Completed

NCT Number: NCT06003114

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Alberta Health Services

Edmonton, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Palbociclib

Drug

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

Other names: Ibrance

Primary outcomes

  1. Estimate the median Duration of Treatment (DoT)

    Time frame: Time index of approximately 01 Jan 2016 to 31 March 2022

Secondary outcomes

  1. Number of patients with treatment discontinuation at one-year intervals

    Time frame: Time index of approximately 01 Jan 2016 to 31 March 2022

  2. Number of patients starting at initial dose

    Time frame: Time index of approximately 01 Jan 2016 to 31 March 2022

  3. Time to chemotherapy

    Time frame: Time index of approximately 01 Jan 2016 to 31 March 2022

  4. Clinical Characteristics of Patients

    Time frame: Time index of approximately 01 Jan 2016 to 31 March 2022

  5. Demographical Characteristics of Patients

    Time frame: Time index of approximately 01 Jan 2016 to 31 March 2022

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 21, 2023
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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