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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06624020




Registration number
NCT06624020
Ethics application status
Date submitted
30/09/2024
Date registered
2/10/2024

Titles & IDs
Public title
A Study to Learn About How Medicines Called CDK4/6 Inhibitors Are Used in People With Advanced or Metastatic Breast Cancer in Australia
Scientific title
Characteristics and Real-world Use of Palbociclib and Other CDK4/6is in Naive Patients in Australia: a Retrospective Analysis (ROSIE)
Secondary ID [1] 0 0
ROSIE
Secondary ID [2] 0 0
A5481187
Universal Trial Number (UTN)
Trial acronym
ROSIE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Breast Cancer Patients - HR+/HER2- metastatic breast cancer patients in in Australia
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Demographic characteristic of participants (CDK4/6i cohort): year of birth
Timepoint [1] 0 0
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
Primary outcome [2] 0 0
Demographic characteristic of participants (CDK4/6i cohort): sex
Timepoint [2] 0 0
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
Primary outcome [3] 0 0
Demographic characteristic of participants (CDK4/6i cohort): comorbidities
Timepoint [3] 0 0
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
Primary outcome [4] 0 0
Demographic characteristic of participants (palbociclib cohort): year of Birth
Timepoint [4] 0 0
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
Primary outcome [5] 0 0
Demographic characteristic of participants (palbociclib cohort): comorbidities
Timepoint [5] 0 0
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
Primary outcome [6] 0 0
Demographic characteristic of participants (palbociclib cohort): sex
Timepoint [6] 0 0
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
Primary outcome [7] 0 0
Proportion of patients receiving palbociclib in combination with aromatase inhibitors or fulvestrant
Timepoint [7] 0 0
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
Primary outcome [8] 0 0
Proportion of patients receiving other cancer treatment regimens
Timepoint [8] 0 0
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 [1] 0 0
Treatment continuation rate for palbociclib
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Percentage of participants with modified doses of palbociclib
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
Median Time to Chemotherapy Initiation from Index
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
Number of comorbidities at initiation of different palbociclib formulations
Timepoint [4] 0 0
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

Eligibility
Key inclusion criteria
* 18 years or older when first received CDK4/6i breast cancer treatment
* Patient who has received CDK4/6i during study period
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* There are no exclusion criteria for this study

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/07/2024
Sample size
Target
Accrual to date
Final
1128
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Pfizer Australia - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06624020