Malignant Neoplasm of BreastSIRINCT04654208
Swedish Ibrance Registries Insights (SIRI)
An observational study of Malignant Neoplasm of Breast, run by Pfizer at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm of Breast
- What is being tested?
- palbociclib
- How many people
- 1,500 participants
- Where
- 1 siteSweden
- Study dates
- 15 Dec 2020to 31 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- One or more (≥1) filled prescription of palbociclib (ATC code: L01XE33)
- Age ≥18 years at index date
Who cannot join
- There are no exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PALBOCICLIB TREATMENT PATTERNS IN SWEDISH PATIENTS WITH METASTATIC BREAST CANCER - SWEDISH IBRANCE REGISTRIES INSIGHTS (SIRI)
The main objectives of this study are to describe patient characteristics, treatment patterns and clinical outcomes of patients receiving palbociclib in Swedish clinical practice.
- Conditions
- Malignant Neoplasm of Breast
- Being tested
- palbociclib
- Keywords
- metastatic breast cancer (MBC)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
palbociclibDrug
patients on palbociclib combination treatment
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: palbociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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])
Measured: 01 January 2017 until 30 September 2020
Secondary outcomes (2)
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])
Measured: 01 January 2017 until 30 September 2020
Describe the demographic and clinical characteristics of the patient population receiving palbociclib combination treatment
Measured: 01 January 2017 until 30 September 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start15 Dec 2020
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasm of BreastStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654208
- Sponsor's protocol ID
- A5481158
- Other IDs
- SIRI
- Acronym
- SIRI
- Status last verified
- Oct 2026
- First submitted
- 27 Nov 2020
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PALBOCICLIB TREATMENT PATTERNS IN SWEDISH PATIENTS WITH METASTATIC BREAST CANCER - SWEDISH IBRANCE REGISTRIES INSIGHTS (SIRI)
- ClinicalTrials.gov ID
- NCT04654208
- Acronym / sponsor ID
- SIRI / A5481158
- Conditions
- Malignant Neoplasm of Breast
- Keywords
- metastatic breast cancer (MBC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objectives of this study are to describe patient characteristics, treatment patterns and clinical outcomes of patients receiving palbociclib in Swedish clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HR+/HER2- locally advanced or MBC in combination with an aromatase inhibitor (AI) | – | Drug: palbociclibGroup Description: patients with at least one filled prescription of palbociclib (ATC (anatomic therapeutic chemical classification system ) code: L01XE33) |
| HR+/HER2- locally advanced or MBC cancer in combination with fulvestrant | – | Drug: palbociclibGroup Description: patients with at least one filled prescription of palbociclib ATC (code: L01XE33) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- One or more (≥1) filled prescription of palbociclib (ATC code: L01XE33)
- Age ≥18 years at index date
Key exclusion criteria (1 listed)
- There are no exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| palbociclibpatients on palbociclib combination treatment | Drug | HR+/HER2- locally advanced or MBC cancer in combination with fulvestrant, HR+/HER2- locally advanced or MBC in combination with an aromatase inhibitor (AI) |
Primary outcome
Proportion of patients on treatment
Time frame: 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])
2 secondary outcomes
Proportion of patients alive
Time frame: 01 January 2017 until 30 September 2020
Describe the demographic and clinical characteristics of the patient population receiving palbociclib combination treatment
Time frame: 01 January 2017 until 30 September 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Neoplasm of Breast, run by Pfizer at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients on treatment (time frame: 01 January 2017 until 30 September 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.