A Real-life Study to Understand the Use and Effects of Palbociclib in US Patients With Breast Cancer

Purpose

Palbociclib, the first oral CDK4/6 inhibitor, is an approved medicine indicated for the treatment of a kind of advanced/metastatic breast cancer (MBC), called hormone receptors positive (HR+)/ Human epidermal growth factor receptor 2 negative (HER2-) disease. Palbociclib is given orally in combination with hormonal therapies. The purpose of this study is to better understand how Palbociclib combination is used in real-life conditions and its clinical impact compared with hormonal therapy. The study will also evaluate how long patients take the different CDK 4/6 inhibitor drugs and whether using those drugs impacts the use of chemotherapy later. Male and female patients aged 18 years old or more presenting the following conditions will be selected for the study: - HR+/HER2- MBC - First treatment with Palbociclib, hormonal therapy, or other CDK4/6 inhibitors after MBC diagnosis The study will use data without personal identity, which were obtained from medical records in routine clinical practice.

Conditions

  • Breast Cancer
  • Malignant Neoplasm of Breast

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Criteria

Patients are eligible for the study if they were 18 years of age or older at MBC
diagnosis, had HR+/HER2- confirmed and initiated first line therapy (CDK4/6i, ET, CT, or
other) in the metastatic setting during the period from February 2015 through June 2022
or data cutoff.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Arm Groups

ArmDescriptionAssigned Intervention
Palbociclib + aromatase inhibitor (AI) Oral palbociclib + AI combination treatment regimen as decided by physician
  • Drug: Palbociclib
    CDK4/6 inhibitor
    Other names:
    • Ibrance
  • Drug: Aromatase inhibitor
    Aromatase inhibitor
    Other names:
    • a class of drugs included in the study: letrozole (Femara), anastrozole (Arimidex), and exemestane (Aromasin)
Aromatase inhibitor (AI) Oral AI treatment regimen as decided by physician
  • Drug: Aromatase inhibitor
    Aromatase inhibitor
    Other names:
    • a class of drugs included in the study: letrozole (Femara), anastrozole (Arimidex), and exemestane (Aromasin)
Abemaciclib plus aromatase inhibitor (AI) Oral abemaciclib plus AI treatment regimen as decided by physician
  • Drug: Palbociclib
    CDK4/6 inhibitor
    Other names:
    • Ibrance
  • Drug: Aromatase inhibitor
    Aromatase inhibitor
    Other names:
    • a class of drugs included in the study: letrozole (Femara), anastrozole (Arimidex), and exemestane (Aromasin)
  • Drug: Abemaciclib
    CDK4/6 inhibitor
    Other names:
    • Verzenio
Ribociclib plus aromatase inhibitor (AI) Oral ribociclib plus AI as decided by physician
  • Drug: Aromatase inhibitor
    Aromatase inhibitor
    Other names:
    • a class of drugs included in the study: letrozole (Femara), anastrozole (Arimidex), and exemestane (Aromasin)
  • Drug: Ribociclib
    CDK4/6 inhibitor
    Other names:
    • Kisqali

Recruiting Locations

More Details

NCT ID
NCT06495164
Status
Active, not recruiting
Sponsor
Pfizer

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center