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OpenTrials
Completed

NCT Number: NCT05770713

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Pfizer Canada

Kirkland, Quebec, H9J2M5, Canada

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Number of Participants Classified According to Treatment Pattern

    Time frame: From date of ABC/MBC diagnosis until date of death, date of last follow-up or the end of the study period, whichever came first (maximum follow-up of 67.6 months); available data evaluated over approximately 4.5 months of this retrospective study

    Number of participants according to the treatment patterns for first line, second line and third line were reported in this outcome measure. CDK4/6i included abemaciclib, palbociclib and ribociclib. Endocrine therapy (ET) included anastrozole, exemestane, fulvestrant, letrozole and tamoxifen. Chemotherapy included capecitabine, cisplatin, cyclophosphamide, docetaxel, doxorubicin, eribulin, gemcitabine and paclitaxel.

Secondary outcomes

  1. Number of Participants Classified According to Type of Treatment Before Introduction of CDK4/6 Inhibitor

    Time frame: From date of ABC/MBC diagnosis until introduction of CDK 4/6 inhibitor(anytime between Jan 2016 to May 2016, approximately 4 months); available data evaluated over approximately 4.5 months of this retrospective study

  2. Number of Participants Classified According to Type of Treatment After Introduction of CDK4/6 Inhibitor

    Time frame: From date of introduction of CDK4/6 inhibitor until date of death, date of last follow-up or the end of the study period, whichever came first (approximately 33 months); available data evaluated over approximately 4.5 months of this retrospective study

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Treatment Patterns And Clinical Outcomes Among Patients Receiving CDK4/6 Inhibitors Combinations For HR+/HER2- Advanced/Metastatic Breast Cancer In A Canadian Real World Setting

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 15, 2023
Registry last updated
Jul 22, 2024

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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