A Study to Learn About How Medicines Called CDK4/6 Inhibitors Are Used in People With Advanced or Metastatic Breast Cancer in Australia
- Conditions
- Breast Neoplasms
- Registration Number
- NCT06624020
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1128
- 18 years or older when first received CDK4/6i breast cancer treatment
- Patient who has received CDK4/6i during study period
- There are no exclusion criteria for this study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Demographic characteristic of participants (CDK4/6i cohort): year of birth 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 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 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 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 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 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 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 At any time from 2004; Within 12 months prior to index date; Within 180 from palbociclib discontinuation until data cut-off, Dec 2023
- Secondary Outcome Measures
Name Time Method Treatment continuation rate for palbociclib 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 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 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 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
Trial Locations
- Locations (1)
Pfizer Australia
🇦🇺Sydney, New South Wales, Australia