Swedish Ibrance Registries Insights (SIRI)

Recruiting

• Conditions: Malignant Neoplasm of Breast
• Interventions: Drug: palbociclib

• Registration Number: NCT04654208
• Lead Sponsor: Pfizer

Brief Summary

The main objectives of this study are to describe patient characteristics, treatment patterns and clinical outcomes of patients receiving palbociclib in Swedish clinical practice.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-27
• Study First Submitted QC: 2020-11-27
• Study First Posted: 2020-12-04
• Study Start: 2020-12-15
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-07
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

1. One or more (≥1) filled prescription of palbociclib (ATC code: L01XE33)
2. Age ≥18 years at index date

Exclusion Criteria

There are no exclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HR+/HER2- locally advanced or MBC cancer in combination with fulvestrant	palbociclib	Group Description: patients with at least one filled prescription of palbociclib ATC (code: L01XE33)
HR+/HER2- locally advanced or MBC in combination with an aromatase inhibitor (AI)	palbociclib	Group Description: patients with at least one filled prescription of palbociclib (ATC (anatomic therapeutic chemical classification system ) code: L01XE33)

Primary Outcome Measures

Name	Time	Method
Proportion of patients on treatment	01 January 2017 until 30 September 2020	Proportion of patients who have not discontinued treatment will be assessed at various timepoints (Time Frame: treatment start date through end of study \[assessed up to 48 months\])

Secondary Outcome Measures

Name	Time	Method
Describe the demographic and clinical characteristics of the patient population receiving palbociclib combination treatment	01 January 2017 until 30 September 2020
Proportion of patients alive	01 January 2017 until 30 September 2020	Proportion of patients alive on palbociclib combination treatment at different points in time (Time Frame: treatment start date through end of study \[assessed up to 48 months\])

Trial Locations

Locations (1)

Pfizer AB; 🇸🇪 Sollentuna, Sweden