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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
Date last updated
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


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