A Study to Understand the Treatment Patterns and Patients and Their Clinical Outcomes Who Are Taking Palbociclib in a Real Life Setting in Israel.

An observational study of Metastatic Breast Cancer, run by Pfizer at 1 site in Israel.

Completed

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

Trial summary

The purpose of this study is to understand the treatment patterns, patients and their clinical outcomes in a real life setting in Israel. This study was done in adult breast cancer patients who have started palbociclib combination treatment as per the national basket of health services in January 2018 until August… Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Metastatic Breast Cancer
What is being tested?: palbociclib
How many people: 559 participants
Where: 1 siteIsrael
Study dates: 6 Dec 2020to 30 Nov 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 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: This is a population based retrospective database study that will include patients with metastatic, HR+/ HER2- breast cancer and who initiated first or subsequent lines of treatment with palbociclib. Data will be available from Maccabi Healthcare Services (MHS) database in Israel for patients who received approval for treatment with palbociclib since 01 January 2018 until 31 August 2020.

Who may be able to join

A diagnosis of metastatic breast cancer, based on the National/MHS cancer registry.
Newly diagnosed metastatic breast cancer patients and newly treated with palbociclib within 6 months of diagnosis, in any line of treatment in the metastatic setting.
Available data on palbociclib treatment for at least 6 months.
Continuous healthcare plan enrolment in MHS for at least one year before index date.

Who cannot join

Patients that initiated HER2 inhibitors.

Trial locations and contacts

1 site in 1 country.

Israel1 site

Pfizer Pharmaceuticals Israel Ltd.
Herzliya Pituah, 4672509

Other trials in Israel

About this study

Official title: DEMOGRAPHICS, PATIENT CHARACTERISTICS, TREATMENT PATTERNS AND CLINICAL OUTCOMES OF PATIENTS TREATED WITH PALBOCICLIB IN A REAL LIFE SETTING IN ISRAEL

This study had included adult patients who were prescribed with palbociclib for their breast cancer which had spread to other parts of the body.

Patients are followed for around 3.5 years.

Conditions: Metastatic Breast Cancer
Being tested: palbociclib
Keywords: hormone receptor, positive/human epidermal growth factor 2 - negative (HR+/HER2-)
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

palbociclibDrug
Also called Ibrance
As provided in real world practice

Study groups in NCT04671615
Study group	Role	What they receive
Patients with metastatic, HR+/HER2- breast cancer.		Patients who initiated first or subsequent lines of treatment with palbociclib Receives: Drug: palbociclib

What is being measured

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

Number of Participants Categorized According to Type of Index Combination Treatment Regimen
Number of participants were classified on the basis of type of combination treatment along with palbociclib as first line therapy. Index treatment was palbociclib combination treatment. Index period was defined as duration in which participant initiated palbociclib combination treatment.
Measured: Day 1 of index treatment (any day from 01 January 2018 to 30 June 2020 [index period]), data observed and evaluated during 18 months of this retrospective study
Duration of Index Treatment Per Type of Combination Treatment
Duration in months between the start and stop of therapy was reported. Index treatment was palbociclib combination treatment. Kaplan-Meier method was used for the assessment of this outcome measure.
Measured: Day 1 of index treatment till discontinuation of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Number of Participants Categorized According to Number of Cycles of Index Treatment Per Type of Combination Treatment
Number of participants categorized according to number of cycles of treatment including less than or equal to (<=) 6, greater than (>) 6 to 11, >11 to 20 and >20 cycles were reported. Index treatment was palbociclib combination treatment.
Measured: Day 1 of index treatment till discontinuation of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Number of Participants Categorized According to Initial Palbociclib Dose Per Type of Combination Treatment
Number of participants were categorized according to initial palbociclib dose. Index treatment was palbociclib combination treatment. Index period was defined as duration in which participant initiated palbociclib combination treatment.
Measured: Day 1 of index treatment (any day from 01 January 2018 to 30 June 2020 [index period]), data observed and evaluated during 18 months of this retrospective study
Number of Participants With Modification (Reduction) in Initial Palbociclib Dose Per Type of Combination Treatment
Number of participants who had a reduction in initial palbociclib dose were reported. Index treatment was palbociclib combination treatment.
Measured: Day 1 of index treatment till discontinuation of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Time on Treatment for Subsequent Treatment After Palbociclib Therapy Per Type of Combination Treatment
Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment and included chemotherapy, everolimus, fulvestrant and other. The duration between the start and stop of the post-palbociclib treatment was reported in this outcome measure. Index treatment was palbociclib combination treatment. Kaplan-Meier method was used for the assessment of this outcome measure.
Measured: Day 1 of subsequent treatment till last dose of subsequent treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Percentage of Participants With Ongoing Index Treatment at Month 6 Per Type of Combination Treatment
Percentage of participants with ongoing index treatment at Month 6 were reported. Index treatment was palbociclib combination treatment.
Measured: Day 1 of index treatment up to Month 6 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Percentage of Participants With Ongoing Index Treatment at Month 12 Per Type of Combination Treatment
Percentage of participants with ongoing index treatment at Month 12 were reported. Index treatment was palbociclib combination treatment.
Measured: Day 1 of index treatment up to Month 12 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Percentage of Participants With Ongoing Index Treatment at Month 24 Per Type of Combination Treatment
Percentage of participants with ongoing index treatment at Month 24 were reported. Index treatment was palbociclib combination treatment.
Measured: Day 1 of index treatment up to Month 24 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Number of Participants Who Died Following Initiation of Index Treatment up to Month 6 Per Type of Combination Treatment
Number of participants who died following index treatment up to Month 6 were reported. Index treatment was palbociclib combination treatment.
Measured: Day 1 of index treatment up to Month 6 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Number of Participants Who Died Following Initiation of Index Treatment up to Month 12 Per Type of Combination Treatment
Number of participants who died following index treatment up to Month 12 were reported. Index treatment was palbociclib combination treatment.
Measured: Day 1 of index treatment up to Month 12 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Number of Participants Who Died Following Initiation of Index Treatment up to Month 24 Per Type of Combination Treatment
Number of participants who died following index treatment up to Month 24 were reported. Index treatment is palbociclib combination treatment.
Measured: Day 1 of index treatment up to Month 24 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 6 Per Type of Combination Treatment
Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment. Number of participants who advanced and did not advance to a subsequent treatment up to Month 6 were reported. Index treatment is palbociclib combination treatment.
Measured: Day 1 of index treatment up to Month 6 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 12 Per Type of Combination Treatment
Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment. Number of participants who advanced and did not advance to a subsequent treatment up to Month 12 were reported. Index treatment is palbociclib combination treatment.
Measured: Day 1 of index treatment up to Month 12 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 24 Per Type of Combination Treatment
Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment. Number of participants who advanced and did not advance to a subsequent treatment up to Month 24 were reported. Index treatment is palbociclib combination treatment.
Measured: Day 1 of index treatment up to Month 24 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Time to Initiation of Chemotherapy After Cessation of Initial Palbociclib Therapy Per Type of Combination Treatment
Time to initiation of chemotherapy was the duration from end of index treatment up to start of chemotherapy. Index treatment is palbociclib combination treatment.
Measured: From cessation of index treatment up to initiation of chemotherapy (during 01 January 2018 to 31 December 2020 [approximately 36 months]); data observed and evaluated during 18 months of this retrospective study
Time to Initiation of Next Treatment (TTNT) From Initiation of Palbociclib Treatment Per Type of Combination Treatment
TTNT was defined as the interval between the start of the index treatment date and the date of the next-line treatment. Participants who did not advance to the next treatment were censored on the study end date or death, whichever occurred first. Index treatment is palbociclib combination treatment. Kaplan-Meier method was used for the assessment of this outcome measure.
Measured: Day 1 of index treatment up to initiation of next treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months 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.

6 Dec 202030 Nov 2022

First posted17 Dec 2020
Study start6 Dec 2020
Primary completion30 Nov 2022
Study completion30 Nov 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for 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: 559 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04671615
Sponsor's protocol ID: A5481160
Other IDs: NCT04671615
Status last verified: Nov 2025
First submitted: 24 Nov 2020
Last updated: 10 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
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.

Publications

Moser SS, Mazursky OF, Shalev H, Apter L, Chodick G, Siegelmann-Danieli N. Real-world outcomes of patients with metastatic endocrine-responsive breast cancer receiving palbociclib-based combinations. Future Oncol. 2023 Jul;19(21):1473-1483. doi: 10.2217/fon-2023-0176. Epub 2023 Aug 2.
PubMed 37529919

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

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Study at a glance

From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: DEMOGRAPHICS, PATIENT CHARACTERISTICS, TREATMENT PATTERNS AND CLINICAL OUTCOMES OF PATIENTS TREATED WITH PALBOCICLIB IN A REAL LIFE SETTING IN ISRAEL
ClinicalTrials.gov ID: NCT04671615
Acronym / sponsor ID: A5481160
Conditions: Metastatic Breast Cancer
Keywords: hormone receptor, positive/human epidermal growth factor 2 - negative (HR+/HER2-)
Study type: Observational
Recruitment status: Completed
Enrolment: 559 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 6 Dec 2020 (actual)
Primary completion: 30 Nov 2022 (actual)
Study completion: 30 Nov 2022 (actual)
First posted: 17 Dec 2020 (actual)
Results: Posted 18 Aug 2023

Clinical summary

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

This study had included adult patients who were prescribed with palbociclib for their breast cancer which had spread to other parts of the body.

Patients are followed for around 3.5 years.

Study design

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

Arm	Type	Receives
Patients with metastatic, HR+/HER2- breast cancer.	–	Drug: palbociclibPatients who initiated first or subsequent lines of treatment with palbociclib

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: This is a population based retrospective database study that will include patients with metastatic, HR+/ HER2- breast cancer and who initiated first or subsequent lines of treatment with palbociclib. Data will be available from Maccabi Healthcare Services (MHS) database in Israel for patients who received approval for treatment with palbociclib since 01 January 2018 until 31 August 2020.

Key inclusion criteria (4 listed)

A diagnosis of metastatic breast cancer, based on the National/MHS cancer registry.
Newly diagnosed metastatic breast cancer patients and newly treated with palbociclib within 6 months of diagnosis, in any line of treatment in the metastatic setting.
Available data on palbociclib treatment for at least 6 months.
Continuous healthcare plan enrolment in MHS for at least one year before index date.

Key exclusion criteria (1 listed)

Patients that initiated HER2 inhibitors.

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: IbranceAs provided in real world practice	Drug	Patients with metastatic, HR+/HER2- breast cancer.

Primary outcome

Number of Participants Categorized According to Type of Index Combination Treatment Regimen
Time frame: Day 1 of index treatment (any day from 01 January 2018 to 30 June 2020 [index period]), data observed and evaluated during 18 months of this retrospective study
Number of participants were classified on the basis of type of combination treatment along with palbociclib as first line therapy. Index treatment was palbociclib combination treatment. Index period was defined as duration in which participant initiated palbociclib combination treatment.
Duration of Index Treatment Per Type of Combination Treatment
Time frame: Day 1 of index treatment till discontinuation of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Duration in months between the start and stop of therapy was reported. Index treatment was palbociclib combination treatment. Kaplan-Meier method was used for the assessment of this outcome measure.
Number of Participants Categorized According to Number of Cycles of Index Treatment Per Type of Combination Treatment
Time frame: Day 1 of index treatment till discontinuation of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Number of participants categorized according to number of cycles of treatment including less than or equal to (<=) 6, greater than (>) 6 to 11, >11 to 20 and >20 cycles were reported. Index treatment was palbociclib combination treatment.
Number of Participants Categorized According to Initial Palbociclib Dose Per Type of Combination Treatment
Time frame: Day 1 of index treatment (any day from 01 January 2018 to 30 June 2020 [index period]), data observed and evaluated during 18 months of this retrospective study
Number of participants were categorized according to initial palbociclib dose. Index treatment was palbociclib combination treatment. Index period was defined as duration in which participant initiated palbociclib combination treatment.
Number of Participants With Modification (Reduction) in Initial Palbociclib Dose Per Type of Combination Treatment
Time frame: Day 1 of index treatment till discontinuation of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Number of participants who had a reduction in initial palbociclib dose were reported. Index treatment was palbociclib combination treatment.
Time on Treatment for Subsequent Treatment After Palbociclib Therapy Per Type of Combination Treatment
Time frame: Day 1 of subsequent treatment till last dose of subsequent treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment and included chemotherapy, everolimus, fulvestrant and other. The duration between the start and stop of the post-palbociclib treatment was reported in this outcome measure. Index treatment was palbociclib combination treatment. Kaplan-Meier method was used for the assessment of this outcome measure.
Percentage of Participants With Ongoing Index Treatment at Month 6 Per Type of Combination Treatment
Time frame: Day 1 of index treatment up to Month 6 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Percentage of participants with ongoing index treatment at Month 6 were reported. Index treatment was palbociclib combination treatment.
Percentage of Participants With Ongoing Index Treatment at Month 12 Per Type of Combination Treatment
Time frame: Day 1 of index treatment up to Month 12 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Percentage of participants with ongoing index treatment at Month 12 were reported. Index treatment was palbociclib combination treatment.
Percentage of Participants With Ongoing Index Treatment at Month 24 Per Type of Combination Treatment
Time frame: Day 1 of index treatment up to Month 24 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Percentage of participants with ongoing index treatment at Month 24 were reported. Index treatment was palbociclib combination treatment.
Number of Participants Who Died Following Initiation of Index Treatment up to Month 6 Per Type of Combination Treatment
Time frame: Day 1 of index treatment up to Month 6 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Number of participants who died following index treatment up to Month 6 were reported. Index treatment was palbociclib combination treatment.
Number of Participants Who Died Following Initiation of Index Treatment up to Month 12 Per Type of Combination Treatment
Time frame: Day 1 of index treatment up to Month 12 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Number of participants who died following index treatment up to Month 12 were reported. Index treatment was palbociclib combination treatment.
Number of Participants Who Died Following Initiation of Index Treatment up to Month 24 Per Type of Combination Treatment
Time frame: Day 1 of index treatment up to Month 24 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Number of participants who died following index treatment up to Month 24 were reported. Index treatment is palbociclib combination treatment.
Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 6 Per Type of Combination Treatment
Time frame: Day 1 of index treatment up to Month 6 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment. Number of participants who advanced and did not advance to a subsequent treatment up to Month 6 were reported. Index treatment is palbociclib combination treatment.
Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 12 Per Type of Combination Treatment
Time frame: Day 1 of index treatment up to Month 12 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment. Number of participants who advanced and did not advance to a subsequent treatment up to Month 12 were reported. Index treatment is palbociclib combination treatment.
Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 24 Per Type of Combination Treatment
Time frame: Day 1 of index treatment up to Month 24 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment. Number of participants who advanced and did not advance to a subsequent treatment up to Month 24 were reported. Index treatment is palbociclib combination treatment.
Time to Initiation of Chemotherapy After Cessation of Initial Palbociclib Therapy Per Type of Combination Treatment
Time frame: From cessation of index treatment up to initiation of chemotherapy (during 01 January 2018 to 31 December 2020 [approximately 36 months]); data observed and evaluated during 18 months of this retrospective study
Time to initiation of chemotherapy was the duration from end of index treatment up to start of chemotherapy. Index treatment is palbociclib combination treatment.
Time to Initiation of Next Treatment (TTNT) From Initiation of Palbociclib Treatment Per Type of Combination Treatment
Time frame: Day 1 of index treatment up to initiation of next treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
TTNT was defined as the interval between the start of the index treatment date and the date of the next-line treatment. Participants who did not advance to the next treatment were censored on the study end date or death, whichever occurred first. Index treatment is palbociclib combination treatment. Kaplan-Meier method was used for the assessment of this outcome measure.

Results and safety

Results posted to the registry on 18 Aug 2023, 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	559	559

Primary outcome: Number of Participants Categorized According to Type of Index Combination Treatment Regimen

Time frame: Day 1 of index treatment (any day from 01 January 2018 to 30 June 2020 [index period]), data observed and evaluated during 18 months of this retrospective study. Count of participants. Unit: Participants

Measure	Palbociclib n = 559
Palbociclib + Aromatase Inhibitor (AI)	293
Palbociclib + Fulvestrant	266

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

Primary outcome: Duration of Index Treatment Per Type of Combination Treatment

Time frame: Day 1 of index treatment till discontinuation of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study. Median (95% Confidence Interval). Unit: Months

Measure	Palbociclib n = 559
Palbociclib + AI	30.5 (23.7 to 37.2)
Palbociclib + Fulvestrant	12.6 (10.6 to 15.6)

Population analysed: Analysis population included all participants whose data were included and observed in the study. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.

Primary outcome: Number of Participants Categorized According to Number of Cycles of Index Treatment Per Type of Combination Treatment

Measure	Palbociclib n = 559
Palbociclib + AI: <= 6 cycles	44
Palbociclib + AI: >6 - 11 cycles	37
Palbociclib + AI: >11 - 20 cycles	66
Palbociclib + AI: >20 cycles	146
Palbociclib + Fulvestrant: <= 6 cycles	99
Palbociclib + Fulvestrant: >6 - 11 cycles	47
Palbociclib + Fulvestrant: >11 - 20 cycles	52
Palbociclib + Fulvestrant: >20 cycles	68

Primary outcome: Number of Participants Categorized According to Initial Palbociclib Dose Per Type of Combination Treatment

Measure	Palbociclib n = 559
Palbociclib + AI: 75 milligrams (mg)	8
Palbociclib + AI: 100 mg	23
Palbociclib + AI: 125 mg	262
Palbociclib + Fulvestrant: 75 milligrams (mg)	12
Palbociclib + Fulvestrant: 100 mg	26
Palbociclib + Fulvestrant: 125 mg	228

Adverse events

Time frame: All-Cause Mortality: Any death due to any cause that happened was recorded during observation period from 01 January 2018 to 30 June 2022 (approximately 54 months); data observed and evaluated during 18 months of this retrospective study. Due to non-interventional nature of the study adverse events were not collected and recorded, hence time frame not applicable.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Palbociclib	0 of 0	0 of 0	269 of 559

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37529919Moser SS, Mazursky OF, Shalev H, Apter L, Chodick G, Siegelmann-Danieli N. Real-world outcomes of patients with metastatic endocrine-responsive breast cancer receiving palbociclib-based combinations. Future Oncol. 2023 Jul;19(21):1473-1483. doi: 10.2217/fon-2023-0176. Epub 2023 Aug 2.
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 Metastatic Breast Cancer, run by Pfizer at 1 site in Israel.

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 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 10 Dec 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 Israel. 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 Aug 2023). 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?

Number of Participants Categorized According to Type of Index Combination Treatment Regimen (time frame: Day 1 of index treatment (any day from 01 January 2018 to 30 June 2020 [index period]), data observed and evaluated during 18 months of this retrospective study). The study lists 17 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 NCT04671615, 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 10 Dec 2025.