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

NCT06624020 | Completed

• 2 other identifiers: A5481187ROSIE
• Study Type: observational
• Target: 1,128
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Neoplasms

Keywords

breast cancer; metastatic breast cancer

Outcome Measures

Primary Outcomes (8)

• 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

• 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

Secondary Outcomes (4)

• 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

  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

Study Arms (1)

Breast Cancer Patients

HR+/HER2- metastatic breast cancer patients in in Australia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients receiving CDK4/6i for the first time for HR+ HER2- metastatic breast cancer

You may qualify if:

• years or older when first received CDK4/6i breast cancer treatment
• Patient who has received CDK4/6i during study period

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Australia

Sydney, New South Wales, 2000, Australia

Location

Related Publications (1)

• 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.

  PMID: 41952090 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 2, 2024
• Study Start: May 20, 2024
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: June 2, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)