A Real-life Study to Learn About the Use and Effects of the CDK4/6 Inhibitors in Canadian Patients With Breast Cancer.

NCT ID: NCT05770713

Last Updated: 2024-07-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-12

Study Completion Date

2023-02-28

Brief Summary

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CDK4/6 inhibitors are approved medicines indicated for the treatment of a kind of advanced/metastatic breast cancer, called hormone receptors positive (HR+)/ Human epidermal growth factor receptor 2 negative (HER2-) disease. They are given orally in combination with hormonal therapies.

The purpose of this study is to better understand how the CDK4/6 inhibitors combinations are used in real-life conditions and their clinical impact for the treatment of Canadian patients affected by (HR+)/ (HER2-) advanced breast cancer (ABC) or metastatic breast cancer (MBC).

Female patients aged 18 years old or more presenting the following conditions will be selected for the study:

* HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease
* Diagnosis of ABC/MBC between 01 January 2016 and 01 July 2021
* Treatment with CDK4/6 inhibitor

Information will be collected from one single Canadian institution, on each selected real-life patient treated with CDK4/6 inhibitors.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Female patients with HR+/HER2- ABC/MBC who received a CDK4/6i based therapy for their ABC/MBC.

Female patients who received an oral treatment of CDK4/6i based therapy for their ABC/MBC.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease
* Diagnosed with ABC/MBC between 01 Jan 2016 and 01 July 2021
* Treatment with CDK4/6 inhibitor

Exclusion Criteria

* Patient does not have ABC/MBC
* Patient has indicated HR- or HER2+ status
* Patient received a CDK4/6i as part of a clinical trial
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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Pfizer Canada

Kirkland, Quebec, Canada

Site Status

Countries

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Canada

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=A5481178

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

Other Identifiers

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A5481178

Identifier Type: -

Identifier Source: org_study_id

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