Breast NeoplasmsNCT07096024
A Study to Understand About the Study Medicine Palbociclib in Breast Cancer Patients After it is Out in the Japanese Market
An observational study of Breast Neoplasms, run by Pfizer at 1 site in United States.
Trial summary
The purpose of the study is to: compare the chances of getting interstitial lung disease (ILD) in new users of palbociclib plus fulvestrant to new users of fulvestrant alone (using data from before palbociclib was out in the market) look into the factors that can cause ILD in new users of palbociclib. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- palbociclib plus fulvestrant and fulvestrant
- How many people
- 95,637 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2025to 7 Feb 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The source population comprises patients diagnosed with breast cancer that include newly treated with palbociclib and/or other endocrine-based therapies for inoperable or recurrent breast cancer between 25 November 2011 and 31 December 2024
Who may be able to join
- Having prescription records of drugs for endocrine therapy (aromatase inhibitors, SERDs, SERMs, and CDK4/6 inhibitors) from 25 November 2011 to 31 December 2024.
- Having any breast cancer records with definitive diagnosis in the same month as the first prescription date.
- Having any records in MDV database on or before 6 months prior to the first prescription date (<= -180 days: first prescription date = 0 day).
- Having any records in MDV database within 6 months prior to the first prescription date (-180 days to 0 day).
Who cannot join
- Having any records of anti-HER2 medication (e.g., trastuzumab, pertuzumab, lapatinib or trastuzumab emtansine) from 25 November 2011 to 31 December 2024.
- Having any records of second primary cancer with definitive diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ibrance® Post-Marketing Database Study Incidence of Interstitial Lung Disease in Inoperable or Recurrent Breast Cancer Patients Treated With Palbociclib in a Post-marketing Setting: Cohort Study Using the Medical Data Vision (MDV) Database
The purpose of the study is to:
- compare the chances of getting interstitial lung disease (ILD) in new users of palbociclib plus fulvestrant to new users of fulvestrant alone (using data from before palbociclib was out in the market)
- look into the factors that can cause ILD in new users of palbociclib.
Read more
This study uses patient data without giving out any personal information of the patient. This data is taken from a hospital-based claims database of the MDV database, that includes data from more than 400 hospitals in Japan.
This study will use data of patients who are:
- diagnosed with breast cancer that include newly treated with palbociclib and/or other endocrine-based therapies for inoperable or recurrent breast cancer between 25 November 2011 and 30 November 2024.
- Conditions
- Breast Neoplasms
- Being tested
- palbociclib plus fulvestrant, fulvestrant
- Keywords
- Ibrance, Post-Marketing Database Study, Incidence of interstitial lung disease (ILD), inoperable or recurrent breast cancer, palbociclib, Medical Data Vision (MDV)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
palbociclib plus fulvestrantDrug
Also called Ibrance, fulvestrant
Patients treated with the combination of palbociclib and fulvestrant
fulvestrantDrug
Patients treated with fulvestrant alone
| Study group | Role | What they receive |
|---|---|---|
| New prescription of palbociclib with fulvestrant. | Patients treated with the combination of palbociclib and fulvestrant Receives: Drug: palbociclib plus fulvestrant; Drug: fulvestrant | |
| New prescription of fulvestrant monotherapy before the launch of palbociclib | Patients treated with fulvestrant alone Receives: Drug: fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
The hazard ratios of ILD in palbociclib plus fulvestrant to new users of fulvestrant alone
Measured: 25 November 2011 and 30 September 2024
The rate ratios of ILD in palbociclib plus fulvestrant to new users of fulvestrant alone
Measured: 25 November 2011 and 30 September 2024
The rate differences of ILD in palbociclib plus fulvestrant to new users of fulvestrant alone
Measured: 25 November 2011 and 30 September 2024
The incidence rate of ILD by each risk factor in new users of palbociclib
Measured: 25 November 2011 and 30 September 2024
Secondary outcomes (1)
The incidence rate of ILD by each risk factor in new users of endocrine-based therapies including combination with CDK4/6 inhibitors
Measured: 25 November 2011 and 30 September 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start21 Jan 2025
- Primary completion7 Feb 2025
- Study completion7 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- 95,637 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
- NCT07096024
- Sponsor's protocol ID
- A5481117
- Status last verified
- Jun 2026
- First submitted
- 24 Jul 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- 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 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ibrance® Post-Marketing Database Study Incidence of Interstitial Lung Disease in Inoperable or Recurrent Breast Cancer Patients Treated With Palbociclib in a Post-marketing Setting: Cohort Study Using the Medical Data Vision (MDV) Database
- ClinicalTrials.gov ID
- NCT07096024
- Acronym / sponsor ID
- A5481117
- Conditions
- Breast Neoplasms
- Keywords
- Ibrance, Post-Marketing Database Study, Incidence of interstitial lung disease (ILD), inoperable or recurrent breast cancer, palbociclib, Medical Data Vision (MDV)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95,637 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 7 Feb 2025 (actual)
- Study completion
- 7 Feb 2025 (actual)
- First posted
- 31 Jul 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 the study is to:
- compare the chances of getting interstitial lung disease (ILD) in new users of palbociclib plus fulvestrant to new users of fulvestrant alone (using data from before palbociclib was out in the market)
- look into the factors that can cause ILD in new users of palbociclib.
This study uses patient data without giving out any personal information of the patient. This data is taken from a hospital-based claims database of the MDV database, that includes data from more than 400 hospitals in Japan.
This study will use data of patients who are:
- diagnosed with breast cancer that include newly treated with palbociclib and/or other endocrine-based therapies for inoperable or recurrent breast cancer between 25 November 2011 and 30 November 2024.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New prescription of palbociclib with fulvestrant. | – | Drug: palbociclib plus fulvestrant, Drug: fulvestrantPatients treated with the combination of palbociclib and fulvestrant |
| New prescription of fulvestrant monotherapy before the launch of palbociclib | – | Drug: fulvestrantPatients treated with fulvestrant alone |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The source population comprises patients diagnosed with breast cancer that include newly treated with palbociclib and/or other endocrine-based therapies for inoperable or recurrent breast cancer between 25 November 2011 and 31 December 2024
Key inclusion criteria (4 listed)
- Having prescription records of drugs for endocrine therapy (aromatase inhibitors, SERDs, SERMs, and CDK4/6 inhibitors) from 25 November 2011 to 31 December 2024.
- Having any breast cancer records with definitive diagnosis in the same month as the first prescription date.
- Having any records in MDV database on or before 6 months prior to the first prescription date (<= -180 days: first prescription date = 0 day).
- Having any records in MDV database within 6 months prior to the first prescription date (-180 days to 0 day).
Key exclusion criteria (2 listed)
- Having any records of anti-HER2 medication (e.g., trastuzumab, pertuzumab, lapatinib or trastuzumab emtansine) from 25 November 2011 to 31 December 2024.
- Having any records of second primary cancer with definitive diagnosis
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 |
|---|---|---|
| palbociclib plus fulvestrantAlso: Ibrance, fulvestrantPatients treated with the combination of palbociclib and fulvestrant | Drug | New prescription of palbociclib with fulvestrant. |
| fulvestrantPatients treated with fulvestrant alone | Drug | New prescription of fulvestrant monotherapy before the launch of palbociclib, New prescription of palbociclib with fulvestrant. |
Primary outcome
The hazard ratios of ILD in palbociclib plus fulvestrant to new users of fulvestrant alone
Time frame: 25 November 2011 and 30 September 2024
The rate ratios of ILD in palbociclib plus fulvestrant to new users of fulvestrant alone
Time frame: 25 November 2011 and 30 September 2024
The rate differences of ILD in palbociclib plus fulvestrant to new users of fulvestrant alone
Time frame: 25 November 2011 and 30 September 2024
The incidence rate of ILD by each risk factor in new users of palbociclib
Time frame: 25 November 2011 and 30 September 2024
1 secondary outcome
The incidence rate of ILD by each risk factor in new users of endocrine-based therapies including combination with CDK4/6 inhibitors
Time frame: 25 November 2011 and 30 September 2024
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 10 Jul 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 Breast Neoplasms, 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 4 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 10 Jul 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?
The hazard ratios of ILD in palbociclib plus fulvestrant to new users of fulvestrant alone (time frame: 25 November 2011 and 30 September 2024). The study lists 4 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 10 Jul 2026.