Patterns of Prescribing and Monitoring of Palbociclib

Rush

Status: Completed

Conditions: Estrogen Receptor-positive Breast Cancer; Metastatic Breast Cancer; Human Epidermal Growth Factor 2 Negative Carcinoma of Breast; Advanced Breast Cancer

Treatments: Drug: Palbociclib

Study type: Observational

Funder types: Other

Identifiers

NCT03285568

16082509

Details and patient eligibility

About

The purpose of this study is to determine if patients with ER+, human epidermal growth factor 2 negative (HER2-), advanced breast cancer are receiving dosing adjustments and monitoring based on manufacturer recommendations at a tertiary academic medical center.

Full description

This study was a retrospective, single-center study that included women receiving palbociclib for the treatment of ER+, HER2- advanced breast cancer. Exclusion criteria were the presence of brain metastases or active enrollment in a palbociclib clinical trial.

The primary endpoint was the proportion of patients who were maintained on a palbociclib dose according to the adjustment schedule in package insert recommendations.

The secondary endpoints were the number of patients dose adjusted for hematologic toxicities, the number of patients experiencing neutropenia, duration of therapy, progression-free survival (PFS), and adherence to manufacturer monitoring recommendations.

Enrollment: 67 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women at least 18 years old
• ER+, HER2- advanced breast cancer
• receiving palbociclib

Exclusion criteria

• brain metastases
• on palbociclib clinical trial

Trial design

67 participants in 1 patient group

Palbociclib

Description:

women at least 18 years old, with ER+, HER2- advanced breast cancer, and were receiving palbociclib

Treatment:

Drug: Palbociclib