Metastatic Breast CancerNCT05132101
Analysis of the Real-world Prescription Pattern of Palbociclib Combination Therapy With Aromatase Inhibitor as a First Line Therapy in Metastatic Breast Cancer Patients Using the National Health Insurance Claims Data in South Korea
An observational study of Metastatic Breast Cancer, run by Pfizer at 1 site in South Korea.
Trial summary
The objective of this study is to evaluate the real-world prescription patterns of Palbociclib in breast cancer (BC) patients who were treated with Palbociclib in combination with AI as a 1st line of therapy using the national health insurance claims data in South Korea. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Patients who received Palbociclib as first line therapy in MBC setting
- How many people
- 2,758 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Dec 2021to 14 Mar 2022
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: BC patients who were prescribed with Palbociclib in combination with AI for at least 1 cycle during the index period will be selected as the study population.
Who may be able to join
- Patients who were prescribed with palbociclib in combination with AI for at least 1 cycle during the index period
- Patients who were diagnosed with BC during the index period
Who cannot join
- Male
- Prescribed with palbociclib during 12-month period preceding the index date
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Real-world Prescription Pattern of Palbociclib Combination Therapy With Aromatase Inhibitor as a 1st Line Therapy in Metastatic Breast Cancer Patients Using the National Health Insurance Claims Data in South Korea
The objective of this study is to evaluate the real-world prescription patterns of Palbociclib in breast cancer (BC) patients who were treated with Palbociclib in combination with AI as a 1st line of therapy using the national health insurance claims data in South Korea.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Patients who received Palbociclib as first line therapy in MBC setting
- Keywords
- Hormone receptor positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-), 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.
Patients who received Palbociclib as first line therapy in MBC settingDrug
Patients who received Palbociclib as first line therapy in MBC setting
What is being measured
The primary outcome is the main question the study is designed to answer.
Total treatment duration and cycle for Palbociclib
Measured: From index date (Index date: 06 Nov 2012 to 30 Sep 2020) to the end date of last palbociclib prescription (maximum of 34.8 months from the index date)
Secondary outcomes (1)
Assessment on dose modification of Palbociclib as first line of therapy in BC patients in real-world setting.
Measured: From the index date (Index date: 06 Nov 2012 to 30 Sep 2020) to the time of reduction or increase in the dose given in the subsequent Palbociclib prescription (up to 30 Sep 2020)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start20 Dec 2021
- Primary completion14 Mar 2022
- Study completion14 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies 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
- 2,758 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
- NCT05132101
- Sponsor's protocol ID
- A5481167
- Other IDs
- Palbociclib HIRA
- Status last verified
- Jun 2025
- First submitted
- 11 Nov 2021
- Last updated
- 19 Jun 2025
- 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 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Real-world Prescription Pattern of Palbociclib Combination Therapy With Aromatase Inhibitor as a 1st Line Therapy in Metastatic Breast Cancer Patients Using the National Health Insurance Claims Data in South Korea
- ClinicalTrials.gov ID
- NCT05132101
- Acronym / sponsor ID
- A5481167
- Conditions
- Metastatic Breast Cancer
- Keywords
- Hormone receptor positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-), Metastatic Breast Cancer (MBC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,758 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 14 Mar 2022 (actual)
- Study completion
- 14 Mar 2022 (actual)
- First posted
- 24 Nov 2021 (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 objective of this study is to evaluate the real-world prescription patterns of Palbociclib in breast cancer (BC) patients who were treated with Palbociclib in combination with AI as a 1st line of therapy using the national health insurance claims data in South Korea.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- BC patients who were prescribed with Palbociclib in combination with AI for at least 1 cycle during the index period will be selected as the study population.
Key inclusion criteria (2 listed)
- Patients who were prescribed with palbociclib in combination with AI for at least 1 cycle during the index period
- Patients who were diagnosed with BC during the index period
Key exclusion criteria (2 listed)
- Male
- Prescribed with palbociclib during 12-month period preceding the index date
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 |
|---|---|---|
| Patients who received Palbociclib as first line therapy in MBC settingPatients who received Palbociclib as first line therapy in MBC setting | Drug | – |
Primary outcome
Total treatment duration and cycle for Palbociclib
Time frame: From index date (Index date: 06 Nov 2012 to 30 Sep 2020) to the end date of last palbociclib prescription (maximum of 34.8 months from the index date)
1 secondary outcome
Assessment on dose modification of Palbociclib as first line of therapy in BC patients in real-world setting.
Time frame: From the index date (Index date: 06 Nov 2012 to 30 Sep 2020) to the time of reduction or increase in the dose given in the subsequent Palbociclib prescription (up to 30 Sep 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 19 Jun 2025.
- 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 Metastatic Breast Cancer, run by Pfizer at 1 site in South Korea.
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 2 inclusion and 2 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 19 Jun 2025. 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 South Korea. 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?
Total treatment duration and cycle for Palbociclib (time frame: From index date (Index date: 06 Nov 2012 to 30 Sep 2020) to the end date of last palbociclib prescription (maximum of 34.8 months from the index date)). 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 19 Jun 2025.