Treatment Patterns and Clinical Outcomes Among Patients With HR+/HER2- mBC Receiving Palbociclib Combination Therapy in the US Community Oncology Setting.

An observational study of Breast Cancer, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

By leveraging a community-based, cancer-specific electronic healthcare record for this study, we aim to understand treatment patterns and clinical outcomes among patients with HR+/HER2- mBC who received care within the context of a large community oncology network in the United States. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Breast Cancer
How many people: 317 participants
Where: 1 siteUnited States
Study dates: 19 Oct 2019to 1 Apr 2022
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer (mBC) Receiving Palbociclib Combination Therapy, Endocrine Monotherapy Or Fulvestrant Monotherapy In The US Community Oncology Setting

Who may be able to join

Documented diagnosis of HR+/HER2- mBC
Initiated palbociclib + fulvestrant as first-line therapy in the metastatic setting and had at least 2 visits following the index date
Received care at a US oncology site(s) utilizing the full EHR at time of treatment and data are available for research purposes

Who cannot join

Enrollment in an interventional clinical trial during the study period
Evidence of prior treatment with CDK4/6 inhibitors in the metastatic setting
Receipt of treatment indicated for another primary cancer during the study period or history of another primary cancer documented within the US Oncology EHR.

Trial locations and contacts

1 site in 1 country.

United States1 site

Pfizer United States
New York, New York, 10017

Other trials in United States

About this study

Official title: Treatment Patterns And Clinical Outcomes Among Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer (mBC) Receiving Palbociclib in Combination With Fulvestrant (PB+FUL) In The US 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 groups in NCT04460911
Study group	Role	What they receive
PAL + FUL		Patients who initiated palbociclib-fulvestrant combination therapy as first-line or beyond therapy in the advanced or metastatic setting.

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Chemotherapy
Time to chemotherapy was defined as the interval (in weeks) between index treatment (palbociclib +fulvestrant) and start of chemotherapy as documented in the iKnowMed (iKM) EHR database. Participants with ongoing treatment at the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis.
Measured: From start of index treatment until start of chemotherapy or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Number of Participants According to Reasons for Treatment Discontinuation
The number of participants classified according to the reasons for treatment discontinuation were reported in this outcome measure.
Measured: From start of index treatment until stop of index treatment or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Real-World Duration of Treatment (rwDOT)
Real-world duration of treatment (rwDOT) was defined as the interval between the start and stop index treatment as documented in the iKM EHR database. Participants with ongoing treatment at the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis.
Measured: From start of index treatment until stop of index treatment or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Time to Next Treatment (TTNT) From Index Treatment
Time to next treatment (TTNT) was defined as the interval between the start of the index treatment and the date of the next-line treatment as documented in the iKM EHR database. Participants who did not advance to the next treatment within the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis.
Measured: From start of index treatment to date of next line treatment or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Percentage of Participants With Provider Documented Disease Progression
Percentage of participants with provider documented progression (documented as disease has progressed or worsening of disease) is reported in this outcome measure.
Measured: From start of treatment until documented disease progression, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Real-World Time to Tumor Progression (rwTTP)
The rwTTP was measured from the initiation of index treatment to the date of provider-documented progression (documented by provider as disease has progressed or worsening of disease), censoring participants without evidence of provider-documented progression at the last visit date. Kaplan-Meier method was used for analysis.
Measured: From initiation of the index treatment to the date of progression or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Real-World Progression-Free Survival (rwPFS)
The rwPFS was measured from the initiation of the index treatment to the date of progression (documented by provider as disease has progressed or worsening of disease) or date of death due to any cause, censoring participants who were still alive at the end of the study observation period and did not progress at the last visit date. Kaplan-Meier method was used for analysis.
Measured: From initiation of index treatment to date of progression or death due to any cause or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Overall Survival (OS)
Overall survival (OS) was defined as the interval between index treatment and the date of death (any cause) as documented in the Limited Access Death Master File (LADMF), National Death Index (NDI) and the iKM EHR database. Participants who did not die within the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis.
Measured: From start of index treatment until date of death or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Oct 20191 Apr 2022

First posted8 Jul 2020
Study start19 Oct 2019
Primary completion1 Apr 2022
Study completion1 Apr 2022

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.
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: 317 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04460911
Sponsor's protocol ID: A5481128
Other IDs: US oncology
Status last verified: Mar 2023
First submitted: 6 Jul 2020
Last updated: 11 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment Patterns And Clinical Outcomes Among Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer (mBC) Receiving Palbociclib in Combination With Fulvestrant (PB+FUL) In The US Community Oncology Setting
ClinicalTrials.gov ID: NCT04460911
Acronym / sponsor ID: A5481128
Conditions: Breast Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 317 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 19 Oct 2019 (actual)
Primary completion: 1 Apr 2022 (actual)
Study completion: 1 Apr 2022 (actual)
First posted: 8 Jul 2020 (actual)
Results: Posted 11 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
PAL + FUL	–	–Patients who initiated palbociclib-fulvestrant combination therapy as first-line or beyond therapy in the advanced or metastatic setting.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer (mBC) Receiving Palbociclib Combination Therapy, Endocrine Monotherapy Or Fulvestrant Monotherapy In The US Community Oncology Setting

Key inclusion criteria (3 listed)

Documented diagnosis of HR+/HER2- mBC
Initiated palbociclib + fulvestrant as first-line therapy in the metastatic setting and had at least 2 visits following the index date
Received care at a US oncology site(s) utilizing the full EHR at time of treatment and data are available for research purposes

Key exclusion criteria (3 listed)

Enrollment in an interventional clinical trial during the study period
Evidence of prior treatment with CDK4/6 inhibitors in the metastatic setting
Receipt of treatment indicated for another primary cancer during the study period or history of another primary cancer documented within the US Oncology EHR.

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

Time to Chemotherapy
Time frame: From start of index treatment until start of chemotherapy or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Time to chemotherapy was defined as the interval (in weeks) between index treatment (palbociclib +fulvestrant) and start of chemotherapy as documented in the iKnowMed (iKM) EHR database. Participants with ongoing treatment at the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis.
Number of Participants According to Reasons for Treatment Discontinuation
Time frame: From start of index treatment until stop of index treatment or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
The number of participants classified according to the reasons for treatment discontinuation were reported in this outcome measure.
Real-World Duration of Treatment (rwDOT)
Time frame: From start of index treatment until stop of index treatment or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Real-world duration of treatment (rwDOT) was defined as the interval between the start and stop index treatment as documented in the iKM EHR database. Participants with ongoing treatment at the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis.
Time to Next Treatment (TTNT) From Index Treatment
Time frame: From start of index treatment to date of next line treatment or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Time to next treatment (TTNT) was defined as the interval between the start of the index treatment and the date of the next-line treatment as documented in the iKM EHR database. Participants who did not advance to the next treatment within the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis.
Percentage of Participants With Provider Documented Disease Progression
Time frame: From start of treatment until documented disease progression, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Percentage of participants with provider documented progression (documented as disease has progressed or worsening of disease) is reported in this outcome measure.
Real-World Time to Tumor Progression (rwTTP)
Time frame: From initiation of the index treatment to the date of progression or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
The rwTTP was measured from the initiation of index treatment to the date of provider-documented progression (documented by provider as disease has progressed or worsening of disease), censoring participants without evidence of provider-documented progression at the last visit date. Kaplan-Meier method was used for analysis.
Real-World Progression-Free Survival (rwPFS)
Time frame: From initiation of index treatment to date of progression or death due to any cause or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
The rwPFS was measured from the initiation of the index treatment to the date of progression (documented by provider as disease has progressed or worsening of disease) or date of death due to any cause, censoring participants who were still alive at the end of the study observation period and did not progress at the last visit date. Kaplan-Meier method was used for analysis.
Overall Survival (OS)
Time frame: From start of index treatment until date of death or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)
Overall survival (OS) was defined as the interval between index treatment and the date of death (any cause) as documented in the Limited Access Death Master File (LADMF), National Death Index (NDI) and the iKM EHR database. Participants who did not die within the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. Kaplan-Meier method was used for analysis.

Results and safety

Results posted to the registry on 11 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Palbociclib + Fulvestrant	317	317

Primary outcome: Time to Chemotherapy

Time frame: From start of index treatment until start of chemotherapy or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study). Median (95% Confidence Interval). Unit: Weeks

Measure	Palbociclib + Fulvestrant n = 317
Value	NA (33.5 to NA)

Population analysed: Analysis population included all eligible participants whose data were retrieved and observed in this study.

Primary outcome: Number of Participants According to Reasons for Treatment Discontinuation

Time frame: From start of index treatment until stop of index treatment or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study). Count of participants. Unit: Participants

Measure	Palbociclib + Fulvestrant n = 250
Provider-documented disease progression	133
Death	20
Insurance/cost-related	1
Patient preference	15
Toxicity	44
Other	17
No information	20

Population analysed: Analysis population included all eligible participants whose data were retrieved and observed in this study. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Primary outcome: Real-World Duration of Treatment (rwDOT)

Measure	Palbociclib + Fulvestrant n = 317
Value	15.8 (13.7 to 18.4)

Population analysed: Analysis population included all eligible participants whose data were retrieved and observed in this study.

Primary outcome: Time to Next Treatment (TTNT) From Index Treatment

Time frame: From start of index treatment to date of next line treatment or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study). Median (95% Confidence Interval). Unit: Weeks

Measure	Palbociclib + Fulvestrant n = 317
Value	16.8 (14.7 to 22.0)

Population analysed: Analysis population included all eligible participants whose data were retrieved and observed in this study.

Adverse events

Time frame: For adverse events, not applicable as adverse events were not collected during the study. For all-cause mortality, from start of index treatment until end of study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Palbociclib + Fulvestrant	0 of 0	0 of 0	92 of 317

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

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 3 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 11 Jan 2024. 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 11 Jan 2024). 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?

Time to Chemotherapy (time frame: From start of index treatment until start of chemotherapy or censoring date, during study observation period maximum up to approximately 53 months (data was retrieved and observed during 2.5 years of this retrospective study)). 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 NCT04460911.

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 11 Jan 2024.