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

Part of paid clinical trials in New York, New York.

Sponsor
Pfizer
Study ID
NCT06495164
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Palbociclib — DRUG
    CDK4/6 inhibitor
  • Aromatase inhibitor — DRUG
    Aromatase inhibitor
  • Ribociclib — DRUG
    CDK4/6 inhibitor
  • Abemaciclib — DRUG
    CDK4/6 inhibitor

Study Details

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.

Key Dates

Start date
Jun 24, 2024
Status verified
Nov 2025
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
1 participants (estimated)

Arms

  • Arm: Palbociclib + aromatase inhibitor (AI)
    Oral palbociclib + AI combination treatment regimen as decided by physician
  • Arm: Aromatase inhibitor (AI)
    Oral AI treatment regimen as decided by physician
  • Arm: Abemaciclib plus aromatase inhibitor (AI)
    Oral abemaciclib plus AI treatment regimen as decided by physician
  • Arm: Ribociclib plus aromatase inhibitor (AI)
    Oral ribociclib plus AI as decided by physician

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From start of index line of therapy to death, February 2015 - December 2022 or data cutoff ]

Locations (1)

FacilityCityStateZIPSite coordinators
Pfizer New YorkNew YorkNew York10001-

Find similar trials in New York, NY

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Pfizer New York· New York, NY

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