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OpenTrials
Completed

NCT Number: NCT06624020

A Study to Learn About How Medicines Called CDK4/6 Inhibitors Are Used in People With Advanced or Metastatic Breast Cancer in Australia

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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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Australia

Sydney, New South Wales, 2000, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Demographic characteristic of participants (CDK4/6i cohort): year of birth

    Time frame: 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

  2. Demographic characteristic of participants (CDK4/6i cohort): sex

    Time frame: 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

  3. Demographic characteristic of participants (CDK4/6i cohort): comorbidities

    Time frame: 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

  4. Demographic characteristic of participants (palbociclib cohort): year of Birth

    Time frame: 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

  5. Demographic characteristic of participants (palbociclib cohort): comorbidities

    Time frame: 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

  6. Demographic characteristic of participants (palbociclib cohort): sex

    Time frame: 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

  7. Proportion of patients receiving palbociclib in combination with aromatase inhibitors or fulvestrant

    Time frame: 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

  8. Proportion of patients receiving other cancer treatment regimens

    Time frame: 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

  1. Treatment continuation rate for palbociclib

    Time frame: 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

  2. Percentage of participants with modified doses of palbociclib

    Time frame: 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

  3. Median Time to Chemotherapy Initiation from Index

    Time frame: 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

  4. Number of comorbidities at initiation of different palbociclib formulations

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Characteristics and Real-world Use of Palbociclib and Other CDK4/6is in Naive Patients in Australia: a Retrospective Analysis (ROSIE)

Acronym: ROSIE

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 2, 2024
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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