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

NCT ID: NCT06003114

Last Updated: 2024-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

472 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-06

Study Completion Date

2024-02-22

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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First-line patients on Palbociclib

Participants taking oral palbociclib as prescribed in first-line treatment

Palbociclib

Intervention Type DRUG

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

Interventions

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Palbociclib

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

Intervention Type DRUG

Other Intervention Names

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Ibrance

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Alberta Health Services

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=A5481183

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

Other Identifiers

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PALCAN

Identifier Type: OTHER

Identifier Source: secondary_id

A5481183

Identifier Type: -

Identifier Source: org_study_id

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