Breast CancerNCT04498481
TREATMENT AND MONITORING PATTERNS AND CLINICAL OUTCOMES IN PATIENTS RECEIVING PALBOCICLIB COMBINATION TREATMENT (WITH AI OR FULVESTRANT) FOR HR+/HER2- A/MBC IN A COMMUNITY ONCOLOGY SETTING.
An observational study of Breast Cancer, run by Pfizer at 1 site in United States.
Trial summary
This is a retrospective, observational study that will document the treatment and monitoring patterns and clinical outcomes of patients diagnosed with HR+/HER2- a/mBC who received Palbociclib combination therapy with aromatase inhibitors or fulvestrant in the a/mBC community oncology setting. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 1 Jul 2018
- 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: The study will include adult patients aged 18 years and older, diagnosed with HR+/HER2- a/mBC who received Palbociclib combination therapy with AI or fulvestrant on or after 2/3/2015.
Who may be able to join
- Patients who are represented in the Vector Oncology Data Warehouse who meet all of the following criteria will be eligible for inclusion in the study.
- Female.
- Diagnosis of female breast cancer with evidence of metastatic disease or advanced disease.
- Diagnosis (confirmed by clinical review) of advanced or metastatic breast cancer at any time, defined as breast cancer at stage IIIb, stage IIIc, or stage IV or identified as having distant metastasis.
- Indication in the record of ER or PR positive disease, or absence of any indication of ER and PR negative disease (ie, patients are eligible without affirmative indication of ER/PR+ status as long as ER/PR- indication is not present).
- Receipt of a palbociclib plus aromatase inhibitor (AI) or palbociclib plus fulvestrant regimen on 2/3/2015 or later in the advanced and metastatic setting. Data collection will prioritize accrual of patients with 1L use of palbociclib plus AI and with 2L use of palbociclib plus fulvestrant before collecting other use of palbociclib users.
- Age greater than or equal to 18 years at A/MBC diagnosis.
Who cannot join
- -There are no exclusion criteria for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TREATMENT AND MONITORING PATTERNS AND CLINICAL OUTCOMES IN PATIENTS RECEIVING PALBOCICLIB PLUS AROMATASE INHIBITOR OR PALBOCICLIB PLUS FULVESTRANT AS TREATMENT OF HORMONE RECEPTOR POSITIVE (HR+)/HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE (HER2-) ADVANCED OR METASTATIC BREAST CANCER IN A REAL WORLD COMMUNITY ONCOLOGY SETTING
This is a retrospective, observational study that will document the treatment and monitoring patterns and clinical outcomes of patients diagnosed with HR+/HER2- a/mBC who received Palbociclib combination therapy with aromatase inhibitors or fulvestrant in the a/mBC community oncology setting.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients | HR+/HER2- advanced/metastatic breast cancer patients in the USA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients receiving various cancer treatment regimens
Measured: A/MBC diagnosis through end of study (assessed up to 24 months)
Proportion of patients receiving each therapy sequence across lines
Measured: A/MBC diagnosis through end of study (assessed up to 24 months)
Treatment persistence
Measured: A/MBC diagnosis through end of study (assessed up to 24 months)
Progression Free Survival (PFS)
Measured: A/MBC diagnosis through end of study (assessed up to 24 months)
Overall Survival (OS)
Measured: A/MBC diagnosis through end of study (assessed up to 24 months)
Tumor response rate
Measured: A/MBC diagnosis through end of study (assessed up to 24 months)
Proportion of patients that experience dose adjustment
Measured: A/MBC diagnosis through end of study (assessed up to 24 months)
Proportion of patients who discontinue therapy
Measured: A/MBC diagnosis through end of study (assessed up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start1 Mar 2018
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 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
- NCT04498481
- Sponsor's protocol ID
- A5481095
- Status last verified
- Feb 2026
- First submitted
- 3 Aug 2020
- Last updated
- 27 Feb 2026
- Results posted
- 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
Robert N, Chen C, Doan J, Venkatasetty D, Espirito JL, Aguilar KM. Real-world study of patients with HR+/ HER2- metastatic breast cancer treated with palbociclib and fulvestrant. Future Oncol. 2025 Jan;21(1):83-94. doi: 10.1080/14796694.2024.2442302. Epub 2025 Jan 15.
PubMed 39810652
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TREATMENT AND MONITORING PATTERNS AND CLINICAL OUTCOMES IN PATIENTS RECEIVING PALBOCICLIB PLUS AROMATASE INHIBITOR OR PALBOCICLIB PLUS FULVESTRANT AS TREATMENT OF HORMONE RECEPTOR POSITIVE (HR+)/HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE (HER2-) ADVANCED OR METASTATIC BREAST CANCER IN A REAL WORLD COMMUNITY ONCOLOGY SETTING
- ClinicalTrials.gov ID
- NCT04498481
- Acronym / sponsor ID
- A5481095
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 4 Aug 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.
This is a retrospective, observational study that will document the treatment and monitoring patterns and clinical outcomes of patients diagnosed with HR+/HER2- a/mBC who received Palbociclib combination therapy with aromatase inhibitors or fulvestrant in the a/mBC community oncology setting.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients | – | –HR+/HER2- advanced/metastatic breast cancer patients in the USA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include adult patients aged 18 years and older, diagnosed with HR+/HER2- a/mBC who received Palbociclib combination therapy with AI or fulvestrant on or after 2/3/2015.
Key inclusion criteria (7 listed)
- Patients who are represented in the Vector Oncology Data Warehouse who meet all of the following criteria will be eligible for inclusion in the study.
- Female.
- Diagnosis of female breast cancer with evidence of metastatic disease or advanced disease.
- Diagnosis (confirmed by clinical review) of advanced or metastatic breast cancer at any time, defined as breast cancer at stage IIIb, stage IIIc, or stage IV or identified as having distant metastasis.
- Indication in the record of ER or PR positive disease, or absence of any indication of ER and PR negative disease (ie, patients are eligible without affirmative indication of ER/PR+ status as long as ER/PR- indication is not present).
Key exclusion criteria (1 listed)
- -There are no exclusion criteria for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients receiving various cancer treatment regimens
Time frame: A/MBC diagnosis through end of study (assessed up to 24 months)
Proportion of patients receiving each therapy sequence across lines
Time frame: A/MBC diagnosis through end of study (assessed up to 24 months)
Treatment persistence
Time frame: A/MBC diagnosis through end of study (assessed up to 24 months)
Progression Free Survival (PFS)
Time frame: A/MBC diagnosis through end of study (assessed up to 24 months)
Overall Survival (OS)
Time frame: A/MBC diagnosis through end of study (assessed up to 24 months)
Tumor response rate
Time frame: A/MBC diagnosis through end of study (assessed up to 24 months)
Proportion of patients that experience dose adjustment
Time frame: A/MBC diagnosis through end of study (assessed up to 24 months)
Proportion of patients who discontinue therapy
Time frame: A/MBC diagnosis through end of study (assessed up to 24 months)
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 27 Feb 2026.
- Derived from this study: PubMed 39810652Robert N, Chen C, Doan J, Venkatasetty D, Espirito JL, Aguilar KM. Real-world study of patients with HR+/ HER2- metastatic breast cancer treated with palbociclib and fulvestrant. Future Oncol. 2025 Jan;21(1):83-94. doi: 10.1080/14796694.2024.2442302. Epub 2025 Jan 15.
- 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 7 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 27 Feb 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?
Proportion of patients receiving various cancer treatment regimens (time frame: A/MBC diagnosis through end of study (assessed up to 24 months)). The study lists 8 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 NCT04498481, 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 27 Feb 2026.