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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

1,500

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Dec 2020

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.5 years study duration

First Submitted

Initial submission to the registry

November 27, 2020

Completed

7 days until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed

11 days until next milestone

Study Start

First participant enrolled

December 15, 2020

Completed

5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Completed

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

5.5 years

First QC Date

November 27, 2020

Last Update Submit

March 29, 2026

Conditions

Malignant Neoplasm of Breast

Keywords

metastatic breast cancer (MBC)

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

Proportion of patients alive
01 January 2017 until 30 September 2020
Describe the demographic and clinical characteristics of the patient population receiving palbociclib combination treatment
01 January 2017 until 30 September 2020

Study Arms (2)

HR+/HER2- locally advanced or MBC in combination with an aromatase inhibitor (AI)

Group Description: patients with at least one filled prescription of palbociclib (ATC (anatomic therapeutic chemical classification system ) code: L01XE33)

Drug: palbociclib

HR+/HER2- locally advanced or MBC cancer in combination with fulvestrant

Group Description: patients with at least one filled prescription of palbociclib ATC (code: L01XE33)

Drug: palbociclib

Interventions

palbociclibDRUG

patients on palbociclib combination treatment

HR+/HER2- locally advanced or MBC cancer in combination with fulvestrantHR+/HER2- locally advanced or MBC in combination with an aromatase inhibitor (AI)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

The study population will include all adult (age ≥18 years) patients (male and female) with at least one filled prescription of palbociclib (ATC code: L01XE33) registered in the Swedish Prescribed Drug Register between January 1st, 2017 and June 30th 2020.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pfizerlead

Study Sites (1)

Pfizer Sweden

Sollentuna, Sweden

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

palbociclib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

Pfizer CT.gov Call Center
Pfizer
STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

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

Study Record Dates

First Submitted

November 27, 2020

First Posted

December 4, 2020

Study Start

December 15, 2020

Primary Completion

May 31, 2026

Study Completion

May 31, 2026

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing: Will not share

Locations

SE(1)

Swedish Ibrance Registries Insights (SIRI)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

HR+/HER2- locally advanced or MBC in combination with an aromatase inhibitor (AI)

HR+/HER2- locally advanced or MBC cancer in combination with fulvestrant

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

HR+/HER2- locally advanced or MBC in combination with an aromatase inhibitor (AI)

HR+/HER2- locally advanced or MBC cancer in combination with fulvestrant

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations