---
title: A Study to Learn About How Medicines Called CDK4/6 Inhibitors Are Used in People With Advanced or Metastatic Breast Cancer in Australia
nct_id: NCT06624020
overall_status: COMPLETED
sponsor: Pfizer
study_type: OBSERVATIONAL
primary_condition: Breast Neoplasms
countries: Australia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06624020.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06624020"
ct_last_update_post_date: 2024-10-02
last_seen_at: "2026-05-12T06:10:18.213Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study to Learn About How Medicines Called CDK4/6 Inhibitors Are Used in People With Advanced or Metastatic Breast Cancer in Australia

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

**NCT ID:** [NCT06624020](https://clinicaltrials.gov/study/NCT06624020)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 1128
- **Lead Sponsor:** Pfizer
- **Conditions:** Breast Neoplasms
- **Start Date:** 2024-05-20
- **Completion Date:** 2024-07-31
- **CT.gov Last Update:** 2024-10-02

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Breast Cancer Patients** — HR+/HER2- metastatic breast cancer patients in in Australia

## Primary Outcomes

- **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)_
- **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)_
- **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)_
- **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)_
- **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)_
- **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)_
- **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)_
- **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

- **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)_
- **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)_
- **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)_
- **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)_

## Locations (1)

- Pfizer Australia, Sydney, New South Wales, Australia

## Recent Field Changes (last 30 days)

- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.pfizer australia|sydney|new south wales|australia` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06624020.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06624020*  
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