Advanced or Metastatic Breast CancerNCT06962969
A Study to Understand the Patients Confirmed to Have Advanced or Metastatic Breast Cancer and Receiving Palbociclib Treatment Using a Real-world Database
An observational study of Advanced or Metastatic Breast Cancer, run by Pfizer at 1 site in United States.
Trial summary
The purpose of this real-world study is to look at breast cancer patients receiving Palbociclib using a large real-world database collected under real-world practice. This study also looks at the safety of Ibrance, including any side effects. Side effects are undesired effects of a medicine or other type of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced or Metastatic Breast Cancer
- What is being tested?
- Ibrance
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2025to 23 Oct 2025
- 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: Study participants will be patients diagnosed with HR(+)/HER2(-) advanced/metastatic breast cancer between August 29, 2015 and September 30, 2023 who meet the general prescribing criteria for Palbociclib in South Korea according to the national product manual, and who meet the following inclusion and exclusion criteria, as determined by data from one year prior to the Ibrance approval date
Who may be able to join
- Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Adult women (≥ 18 years of age) with at least one visit with a breast cancer ICD10 diagnosis code (C50.x)
- Patients with locally advanced breast cancer or metastatic breast cancer with a staging classification of stage III, stage IV (distant metastases).
- Patients with a laboratory test positive for hormone receptor (HR) and negative for human epithelial growth factor receptor 2 (HER2) before or up to 60 days after advanced/metastatic breast cancer diagnosis date.
- HR-positive is defined as any positive test for estrogen receptor or progesterone receptor.
- HER2-negative is defined as any HER2-negative test and the absence of a positive test (immunohistochemistry positive (3+), fluorescence in situ hybridization positive/amplified).
- Patients who received at least one initial prescription of Ibrance following a diagnosis of advanced/metastatic breast cancer
Who cannot join
- Patients meeting any of the following criteria will not be included in the study:
- Breast cancer with HR-negative and HER2-positive on laboratory testing.
- More than a 90-day gap between breast cancer diagnosis date and next visit.
- Patients who treated as off-label
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-world Database Study to Observe Safety and Effectiveness of Ibrance
The purpose of this real-world study is to look at breast cancer patients receiving Palbociclib using a large real-world database collected under real-world practice. This study also looks at the safety of Ibrance, including any side effects. Side effects are undesired effects of a medicine or other type of treatment.
This study will include the data of the following participants:
Read more
- Adult women (more than18 years of age) with at least one visit with a breast cancer
- Patients with locally advanced breast cancer or metastatic breast cancer with a staging classification of stage III, stage IV. Advanced cancer is a term that is often used to describe cancer that is unlikely to be cured. Metastatic cancer is the cancer which is spread from the place where it started to other places in the body.
- Patients with a laboratory test positive for hormone receptor and negative for HER2 before or up to 60 days after advanced/metastatic breast cancer diagnosis date.
- Patients who received at least one initial prescription of Ibrance following a diagnosis of advanced/metastatic breast cancer.
This study will look at the safety of palbociclib treatment by looking at the number and severity of the side effects.
- Conditions
- Advanced or Metastatic Breast Cancer
- Being tested
- Ibrance
- Keywords
- breast cancer, Palbociclib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbranceDrug
Also called Palbociclib
Patients who received at least one initial prescription of Ibrance following a diagnosis of advanced/metastatic breast cancer
| Study group | Role | What they receive |
|---|---|---|
| Ibrance (palbociclib) | Patients who received at least one initial prescription of Ibrance following a diagnosis of advanced/metastatic breast cancer Receives: Drug: Ibrance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events that occur during treatment
Measured: From index date to last dose plus 28 days. Index is defined as the date of first prescription of Ibrance on participants diagnosed between 29 Aug 2015 through 30 Sep 2023
Number of participants with associated risk factors
Measured: From index date to last dose plus 28 days. Index is defined as the date of first prescription of Ibrance on participants diagnosed between 29 Aug 2015 through 30 Sep 2023
Secondary outcomes (2)
Overall Survival (OS)
Measured: From baseline to the date of death or censoring date, whichever occurs first on participants diagnosed between 29 Aug 2015 through 30 Sep 2023
Real-World Tumor Response (rwTR)
Measured: From baseline to the date of death or censoring date, whichever occurs first on participants diagnosed between 29 Aug 2015 through 30 Sep 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start30 Jun 2025
- Primary completion23 Oct 2025
- Study completion23 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or 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
- 1 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
- NCT06962969
- Sponsor's protocol ID
- A5481186
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2025
- Last updated
- 20 Aug 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Database Study to Observe Safety and Effectiveness of Ibrance
- ClinicalTrials.gov ID
- NCT06962969
- Acronym / sponsor ID
- A5481186
- Conditions
- Advanced or Metastatic Breast Cancer
- Keywords
- breast cancer, Palbociclib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 23 Oct 2025 (actual)
- Study completion
- 23 Oct 2025 (actual)
- First posted
- 8 May 2025 (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 purpose of this real-world study is to look at breast cancer patients receiving Palbociclib using a large real-world database collected under real-world practice. This study also looks at the safety of Ibrance, including any side effects. Side effects are undesired effects of a medicine or other type of treatment.
This study will include the data of the following participants:
- Adult women (more than18 years of age) with at least one visit with a breast cancer
- Patients with locally advanced breast cancer or metastatic breast cancer with a staging classification of stage III, stage IV. Advanced cancer is a term that is often used to describe cancer that is unlikely to be cured. Metastatic cancer is the cancer which is spread from the place where it started to other places in the body.
- Patients with a laboratory test positive for hormone receptor and negative for HER2 before or up to 60 days after advanced/metastatic breast cancer diagnosis date.
- Patients who received at least one initial prescription of Ibrance following a diagnosis of advanced/metastatic breast cancer.
This study will look at the safety of palbociclib treatment by looking at the number and severity of the side effects.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ibrance (palbociclib) | – | Drug: IbrancePatients who received at least one initial prescription of Ibrance following a diagnosis of advanced/metastatic breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be patients diagnosed with HR(+)/HER2(-) advanced/metastatic breast cancer between August 29, 2015 and September 30, 2023 who meet the general prescribing criteria for Palbociclib in South Korea according to the national product manual, and who meet the following inclusion and exclusion criteria, as determined by data from one year prior to the Ibrance approval date
Key inclusion criteria (7 listed)
- Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Adult women (≥ 18 years of age) with at least one visit with a breast cancer ICD10 diagnosis code (C50.x)
- Patients with locally advanced breast cancer or metastatic breast cancer with a staging classification of stage III, stage IV (distant metastases).
- Patients with a laboratory test positive for hormone receptor (HR) and negative for human epithelial growth factor receptor 2 (HER2) before or up to 60 days after advanced/metastatic breast cancer diagnosis date.
- Patients who received at least one initial prescription of Ibrance following a diagnosis of advanced/metastatic breast cancer
Key exclusion criteria (4 listed)
- Breast cancer with HR-negative and HER2-positive on laboratory testing.
- More than a 90-day gap between breast cancer diagnosis date and next visit.
- Patients who treated as off-label
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 |
|---|---|---|
| IbranceAlso: PalbociclibPatients who received at least one initial prescription of Ibrance following a diagnosis of advanced/metastatic breast cancer | Drug | Ibrance (palbociclib) |
Primary outcome
Number of participants with adverse events that occur during treatment
Time frame: From index date to last dose plus 28 days. Index is defined as the date of first prescription of Ibrance on participants diagnosed between 29 Aug 2015 through 30 Sep 2023
Number of participants with associated risk factors
Time frame: From index date to last dose plus 28 days. Index is defined as the date of first prescription of Ibrance on participants diagnosed between 29 Aug 2015 through 30 Sep 2023
2 secondary outcomes
Overall Survival (OS)
Time frame: From baseline to the date of death or censoring date, whichever occurs first on participants diagnosed between 29 Aug 2015 through 30 Sep 2023
Real-World Tumor Response (rwTR)
Time frame: From baseline to the date of death or censoring date, whichever occurs first on participants diagnosed between 29 Aug 2015 through 30 Sep 2023
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 20 Aug 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 Advanced or Metastatic Breast Cancer, run by Pfizer at 1 site in United States.
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 7 inclusion and 4 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 20 Aug 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 United States. 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?
Number of participants with adverse events that occur during treatment (time frame: From index date to last dose plus 28 days. Index is defined as the date of first prescription of Ibrance on participants diagnosed between 29 Aug 2015 through 30 Sep 2023). The study lists 2 primary outcomes in all. 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 20 Aug 2026.