A Study to Learn About How Medicines Called CDK4/6 Inhibitors Are Used in People With Advanced or Metastatic Breast Cancer in Australia

Pfizer1,128 enrolled

Overview

The purpose of this study is to learn about how a class of medicines called CDK4/6 inhibitors, are used for the treatment of breast cancer in patients in Australia. The study looks at how the CDK4/6 inhibitor class of drugs are used for treating breast cancer that is advanced or metastatic (has spread to other parts of the body). This study does not include patients. Instead, this study looks at already available data to describe characteristics (like age and sex) of patients who have already taken these medicines. This study will focus on one of these medicines called palbociclib and will look at the data to learn what amounts of the study medicine (palbociclib) patients receive, and how long patients take it for in the real-world in Australia. This study will also learn what other anti-cancer medicines patients receive, including chemotherapy. Chemotherapy is the treatment that uses medicines to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

Study Type

OBSERVATIONAL

Enrollment

1,128

Conditions

Breast Neoplasms

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years or older when first received CDK4/6i breast cancer treatment * Patient who has received CDK4/6i during study period Exclusion Criteria: * There are no exclusion criteria for this study

Locations (1)

Pfizer Australia

Outcomes

Primary Outcomes

Demographic characteristic of participants (CDK4/6i cohort): year of birth

Time frame: At index date; index date will be defined as the date of dispensation of either any CDK4/6i or palbociclib in the CDK4/6i naive cohort, until Dec 2023

Demographic characteristic of participants (CDK4/6i cohort): sex

Time frame: At index date; index date will be defined as the date of dispensation of either any CDK4/6i or palbociclib in the CDK4/6i naive cohort, until Dec 2023

Demographic characteristic of participants (CDK4/6i cohort): comorbidities

Time frame: Within 12 months prior to index date. Index date will be defined as the date of dispensation of either any CDK4/6i or palbociclib in the CDK4/6i naive cohort, until Dec 2023

Demographic characteristic of participants (palbociclib cohort): year of Birth

Time frame: At index date; index date will be defined as the date of dispensation of either any CDK4/6i or palbociclib in the CDK4/6i naive cohort, until Dec 2023

Demographic characteristic of participants (palbociclib cohort): comorbidities

Time frame: Within 12 months prior to index date. Index date will be defined as the date of dispensation of either any CDK4/6i or palbociclib in the CDK4/6i naive cohort, until Dec 2023

Demographic characteristic of participants (palbociclib cohort): sex

Time frame: At index date; index date will be defined as the date of dispensation of either any CDK4/6i or palbociclib in the CDK4/6i naive cohort, until Dec 2023

Proportion of patients receiving palbociclib in combination with aromatase inhibitors or fulvestrant

Time frame: At index date; Index date will be defined as the date of dispensation of either any CDK4/6i or palbociclib in the CDK4/6i naive cohort, until Dec 2023

Proportion of patients receiving other cancer treatment regimens

Time frame: At any time from 2004; Within 12 months prior to index date; Within 180 from palbociclib discontinuation until data cut-off, Dec 2023

Secondary Outcomes

Treatment continuation rate for palbociclib

Time frame: At 12 and 24 months from index date until Dec 2023. Index date will be defined as the date of dispensation of either any CDK4/6i or palbociclib in the CDK4/6i naive cohort, until Dec 2023

Percentage of participants with modified doses of palbociclib

Time frame: First dose modification, from index date until Dec 2023. Index date will be defined as the date of dispensation of either any CDK4/6i or palbociclib in the CDK4/6i naive cohort, until Dec 2023

Median Time to Chemotherapy Initiation from Index

Time frame: From index date until Dec 2023. Index date will be defined as the date of dispensation of either any CDK4/6i or palbociclib in the CDK4/6i naive cohort, until Dec 2023

Number of comorbidities at initiation of different palbociclib formulations

Time frame: Within 12 months prior to index date. Index date will be defined as the date of dispensation of either any CDK4/6i or palbociclib in the CDK4/6i naive cohort, until Dec 2023