Breast CancerNCT06086340
Study to Compare Overall Survival in Medicare Patients With Metastatic Breast Cancer Treated With a Medicine Called Palbociclib in Combination With Aromatase Inhibitor and Aromatase Inhibitor by Itself.
An observational study of Breast Cancer, run by Pfizer at 1 site in United States.
Trial summary
A retrospective study of de-identified (to preserve patient privacy) patient information from the SEER-Medicare Database to compare overall survival of first line palbociclib + aromatase inhibitor (AI) therapy versus AI therapy alone treatment in women or men aged 65 and older with newly diagnosed hormone receptor… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Palbociclib and Aromatase Inhibitor
- How many people
- 779 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2023to 24 Jan 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Medicare recipients with HR+/HER2- with De Novo metastatic breast cancer
Who may be able to join
- De novo metastatic (stage IV) disease at initial breast cancer diagnosis during 2015-2019
- HR+/HER2- molecular subtype at diagnosis
- Initiated 1L systemic therapy with palbociclib + AI or AI alone
Who cannot join
- Patients will be excluded if their metastatic breast cancer diagnosis was first recorded in a death certificate or at the time of autopsy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Assessment of Overall Survival in Medicare Patients With HR+/HER2- Metastatic Breast Cancer Treated With Palbociclib in Combination With Aromatase Inhibitor (AI vs. AI Alone)
A retrospective study of de-identified (to preserve patient privacy) patient information from the SEER-Medicare Database to compare overall survival of first line palbociclib + aromatase inhibitor (AI) therapy versus AI therapy alone treatment in women or men aged 65 and older with newly diagnosed hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (MBC) in the United States
- Conditions
- Breast Cancer
- Being tested
- Palbociclib, Aromatase Inhibitor
- Keywords
- Breast neoplasm, Hormone receptor-positive Human epidermal growth factor receptor 2 negative (HR+,HER2-), palbociclib, Metastatic, Medicare, SEER-Medicare
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalbociclibDrug
Also called Ibrance
Palbociclib with an aromatase inhibitor therapy
Aromatase InhibitorDrug
Also called letrozole, anastrozole, exemestane
Aromatase Inhibitor Therapy
| Study group | Role | What they receive |
|---|---|---|
| Palbociclib + AI | Adult metastatic breast cancer patients who initiated Palbociclib + an aromatase inhibitor as first line therapy in SEER-Medicare Receives: Drug: Palbociclib; Drug: Aromatase Inhibitor | |
| AI alone | Adult metastatic breast cancer patients who initiated an aromatase inhibitor (alone) as first line therapy Receives: Drug: Aromatase Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival According to Unadjusted Analysis
Overall survival was defined as time in months from the study index date to all cause death. Study index date in this outcome measure was the date of first line of treatment initiation with palbociclib + AI or AI alone after the de novo mBC diagnosis. De novo mBC referred to breast cancer that physician diagnosed for the first time after it had already spread outside of the breast to distant parts of the body. Unadjusted analysis: analysis not considering any covariates, specifically potential differences in baseline characteristics that could confound the association between treatment and survival. Overall survival was assessed using Kaplan-Meier analysis.
Measured: From index date to death (approximately 69.9 months); retrospective data evaluated in 4 months (approximately) of this study
Overall Survival According to Stabilized Inverse Probability of Treatment Weighted (sIPTW) Analysis
Overall survival was defined as time in months from the study index date to all cause death. Study index date in this outcome measure was the date of first line of treatment initiation with palbociclib + AI or AI alone after the de novo mBC diagnosis. De novo mBC referred to breast cancer that physician diagnosed for the first time after it had already spread outside of the breast to distant parts of the body. sIPTW analysis: stabilized inverse probability treatment weighting. This is a statistical method that reweights participants to create groups with similar baseline characteristics. The analysis therefore adjusts for differences in baseline characteristics that could confound the association between treatment and survival. Overall survival was assessed using Kaplan-Meier analysis.
Measured: From index date to death (approximately 69.9 months); retrospective data evaluated in 4 months (approximately) of this study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start29 Sep 2023
- Primary completion24 Jan 2024
- Study completion24 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 779 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
- NCT06086340
- Sponsor's protocol ID
- A5481182
- Other IDs
- Henri 3
- Status last verified
- Nov 2025
- First submitted
- 11 Oct 2023
- Last updated
- 18 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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.
Publications
Brufsky AM, Sandin R, Stergiopoulos S, Chen C, Karanth S, Li B, Esterberg E, Makari D, Candrilli SD, Goyal RK, Rugo HS. Overall Survival With Palbociclib and Aromatase Inhibitor Versus Aromatase Inhibitor Alone in Older Patients With HR+/HER2- Metastatic Breast Cancer. Cancer Med. 2025 Apr;14(7):e70719. doi: 10.1002/cam4.70719.
PubMed 40145289
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Assessment of Overall Survival in Medicare Patients With HR+/HER2- Metastatic Breast Cancer Treated With Palbociclib in Combination With Aromatase Inhibitor (AI vs. AI Alone)
- ClinicalTrials.gov ID
- NCT06086340
- Acronym / sponsor ID
- A5481182
- Conditions
- Breast Cancer
- Keywords
- Breast neoplasm, Hormone receptor-positive Human epidermal growth factor receptor 2 negative (HR+,HER2-), palbociclib, Metastatic, Medicare, SEER-Medicare
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 779 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- 24 Jan 2024 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 17 Oct 2023 (actual)
- Results
- Posted 18 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A retrospective study of de-identified (to preserve patient privacy) patient information from the SEER-Medicare Database to compare overall survival of first line palbociclib + aromatase inhibitor (AI) therapy versus AI therapy alone treatment in women or men aged 65 and older with newly diagnosed hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (MBC) in the United States
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palbociclib + AI | – | Drug: Palbociclib, Drug: Aromatase InhibitorAdult metastatic breast cancer patients who initiated Palbociclib + an aromatase inhibitor as first line therapy in SEER-Medicare |
| AI alone | – | Drug: Aromatase InhibitorAdult metastatic breast cancer patients who initiated an aromatase inhibitor (alone) as first line therapy |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Medicare recipients with HR+/HER2- with De Novo metastatic breast cancer
Key inclusion criteria (3 listed)
- De novo metastatic (stage IV) disease at initial breast cancer diagnosis during 2015-2019
- HR+/HER2- molecular subtype at diagnosis
- Initiated 1L systemic therapy with palbociclib + AI or AI alone
Key exclusion criteria (1 listed)
- Patients will be excluded if their metastatic breast cancer diagnosis was first recorded in a death certificate or at the time of autopsy.
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 |
|---|---|---|
| PalbociclibAlso: IbrancePalbociclib with an aromatase inhibitor therapy | Drug | Palbociclib + AI |
| Aromatase InhibitorAlso: letrozole, anastrozole, exemestaneAromatase Inhibitor Therapy | Drug | AI alone, Palbociclib + AI |
Primary outcome
Overall Survival According to Unadjusted Analysis
Time frame: From index date to death (approximately 69.9 months); retrospective data evaluated in 4 months (approximately) of this study
Overall survival was defined as time in months from the study index date to all cause death. Study index date in this outcome measure was the date of first line of treatment initiation with palbociclib + AI or AI alone after the de novo mBC diagnosis. De novo mBC referred to breast cancer that physician diagnosed for the first time after it had already spread outside of the breast to distant parts of the body. Unadjusted analysis: analysis not considering any covariates, specifically potential differences in baseline characteristics that could confound the association between treatment and survival. Overall survival was assessed using Kaplan-Meier analysis.
Overall Survival According to Stabilized Inverse Probability of Treatment Weighted (sIPTW) Analysis
Time frame: From index date to death (approximately 69.9 months); retrospective data evaluated in 4 months (approximately) of this study
Overall survival was defined as time in months from the study index date to all cause death. Study index date in this outcome measure was the date of first line of treatment initiation with palbociclib + AI or AI alone after the de novo mBC diagnosis. De novo mBC referred to breast cancer that physician diagnosed for the first time after it had already spread outside of the breast to distant parts of the body. sIPTW analysis: stabilized inverse probability treatment weighting. This is a statistical method that reweights participants to create groups with similar baseline characteristics. The analysis therefore adjusts for differences in baseline characteristics that could confound the association between treatment and survival. Overall survival was assessed using Kaplan-Meier analysis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40145289Brufsky AM, Sandin R, Stergiopoulos S, Chen C, Karanth S, Li B, Esterberg E, Makari D, Candrilli SD, Goyal RK, Rugo HS. Overall Survival With Palbociclib and Aromatase Inhibitor Versus Aromatase Inhibitor Alone in Older Patients With HR+/HER2- Metastatic Breast Cancer. Cancer Med. 2025 Apr;14(7):e70719. doi: 10.1002/cam4.70719.
- 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 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 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 18 Nov 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 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?
Yes. Results are posted in the registry (first posted 18 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Survival According to Unadjusted Analysis (time frame: From index date to death (approximately 69.9 months); retrospective data evaluated in 4 months (approximately) of this study). 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?
On the ClinicalTrials.gov record for NCT06086340, which also lists 1 linked publication.
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 18 Nov 2025.