Health TrialsbyHealthPanel

Swedish Ibrance Registries Insights (SIRI)

ConditionMalignant Neoplasm of Breast
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPfizer

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

One or more (≥1) filled prescription of palbociclib (ATC code: L01XE33)

Age ≥18 years at index date

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • palbociclib

    Drug

    patients on palbociclib combination treatment

Treatment groups

1,500 Participants
are divided into 2 treatment groups
Group A: HR+/HER2- locally advanced or MBC in combination with an aromatase inhibitor (AI)1 intervention
Group B: HR+/HER2- locally advanced or MBC cancer in combination with fulvestrant1 intervention

Trial outcomes

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 \[assessed up to 48 months\])

Time frame
01 January 2017 until 30 September 2020

Secondary outcomes

1

Proportion of patients alive

Proportion of patients alive on palbociclib combination treatment at different points in time (Time Frame: treatment start date through end of study \[assessed up to 48 months\])

Time frame
01 January 2017 until 30 September 2020
2

Describe the demographic and clinical characteristics of the patient population receiving palbociclib combination treatment

Time frame
01 January 2017 until 30 September 2020

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pfizer

Lead sponsor

Source ClinicalTrials.gov
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