Clinical trial NCT06624020: A Study to Learn About How Medicines Called CDK4/6 Inhibitors Are Used in People With Advanced or Metastatic Breast Cancer in Australia
Official title: Characteristics and Real-world Use of Palbociclib and Other CDK4/6is in Naive Patients in Australia: a Retrospective Analysis (ROSIE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Keywords: breast cancer
metastatic breast cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-10-02
Enrollment: 1128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receiving CDK4/6i for the first time for HR+ HER2- metastatic breast cancer

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.


Eligibility criteria: 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

Primary outcomes:
measure: Demographic characteristic of participants (CDK4/6i cohort): year of birth
timeFrame: 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
measure: Demographic characteristic of participants (CDK4/6i cohort): sex
timeFrame: 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
measure: Demographic characteristic of participants (CDK4/6i cohort): comorbidities
timeFrame: 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
measure: Demographic characteristic of participants (palbociclib cohort): year of Birth
timeFrame: 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
measure: Demographic characteristic of participants (palbociclib cohort): comorbidities
timeFrame: 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
measure: Demographic characteristic of participants (palbociclib cohort): sex
timeFrame: 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
measure: Proportion of patients receiving palbociclib in combination with aromatase inhibitors or fulvestrant
timeFrame: 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
measure: Proportion of patients receiving other cancer treatment regimens
timeFrame: 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:
measure: Treatment continuation rate for palbociclib
timeFrame: 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
measure: Percentage of participants with modified doses of palbociclib
timeFrame: 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
measure: Median Time to Chemotherapy Initiation from Index
timeFrame: 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
measure: Number of comorbidities at initiation of different palbociclib formulations
timeFrame: 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
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Pfizer Australia
state: New South Wales
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: