Clinical trial · Observational
A Study to Learn About How Medicines Called CDK4/6 Inhibitors Are Used in People With Advanced or Metastatic Breast Cancer in Australia
Characteristics and Real-world Use of Palbociclib and Other CDK4/6is in Naive Patients in Australia: a Retrospective Analysis (ROSIE)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Breast Cancer Patients
- description
- HR+/HER2- metastatic breast cancer patients in in Australia
Primary outcomes (8)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDNott L, Moylan E, Colosimo M, Stratton G, Chiu T, Kouhkamari MH, Hitschfeld M, Michie J, De Boer R. Palbociclib in the Treatment of HR+/ HER2- Advanced or Metastatic Breast Cancer in Australia: A Real-World Retrospective Analysis. Asia Pac J Clin Oncol. 2026 Apr 8. doi: 10.1111/ajco.70108. Online ahead of print. PMID 41952090