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

Pfizer

Status: Active, not recruiting

Conditions: Breast Cancer; Malignant Neoplasm of Breast

Treatments: Drug: Palbociclib; Drug: Abemaciclib; Drug: Aromatase inhibitor; Drug: Ribociclib

Study type: Observational

Funder types: Industry

Identifiers

NCT06495164

A5481189

NCT06495164 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 1 estimated patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

1 participants in 4 patient groups

Palbociclib + aromatase inhibitor (AI)

Description:

Oral palbociclib + AI combination treatment regimen as decided by physician

Treatment:

Drug: Aromatase inhibitor

Drug: Palbociclib

Aromatase inhibitor (AI)

Description:

Oral AI treatment regimen as decided by physician

Treatment:

Drug: Aromatase inhibitor

Abemaciclib plus aromatase inhibitor (AI)

Description:

Oral abemaciclib plus AI treatment regimen as decided by physician

Treatment:

Drug: Aromatase inhibitor

Drug: Abemaciclib

Drug: Palbociclib

Ribociclib plus aromatase inhibitor (AI)

Description:

Oral ribociclib plus AI as decided by physician

Treatment:

Drug: Ribociclib

Drug: Aromatase inhibitor