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| ID | Type | Description | Link |
|---|---|---|---|
| ROSIE | Other Identifier | Alias Study Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast Cancer Patients | HR+/HER2- metastatic breast cancer patients in in Australia |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients receiving CDK4/6i for the first time for HR+ HER2- metastatic breast cancer
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Australia | Sydney | New South Wales | 2000 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41952090 | Derived | Nott 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 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 |
| 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 |
| D017437 |
| Skin and Connective Tissue Diseases |