A Retrospective Non-interventional Study of Breast Cancer Patients Diagnosed With HR+/HER2- Locally Advanced or Metastatic Breast Cancer Treated With Palbociclib in Denmark

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

Completed

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

Trial summary

The objective is to retrospectively describe and assess clinical and demographical characteristics, treatment patterns in a real-world (RW) setting of patients with HR+/HER2- (hormone receptor positive/human epidermal growth factor receptor 2 negative) locally advanced or metastatic breast cancer receiving palbociclib… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Breast Cancer
How many people: 1,054 participants
Where: 1 siteDenmark
Study dates: 1 Feb 2022to 1 Aug 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 HR+/HER2- locally advanced or metastatic breast cancer treated with palbociclib (1st or 2nd line between 01 Jan 2017- 31 Dec 2020).

Who may be able to join

Patients with breast cancer (International Statistical Classification of Diseases and Related Health Problems, 10th Revision [ICD-10]: ICD-10 code for patients with breast cancer [DC50])
A diagnosis of HR+/HER2- locally advanced or metastatic breast cancer
Initiated treatment with palbociclib as either 1st or 2nd line treatment between 01 January 2017 and 31 December 2020
Inclusion date: Date of relapse/stage IV disease/progression leading to initiation of palbociclib+AI/progression leading to initiation of palbociclib+fulvestrant

Who cannot join

There are no exclusion criteria for this study

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Danish Breast Cancer Group
Copenhagen

Other trials in Denmark

About this study

Conditions: Breast Cancer
Keywords: Metastatic Breast Cancer, HR+/ HER2-
Medical subject headings: Breast Neoplasms

What is being measured

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

Progression-Free Survival (PFS) for Participants Who Received Palbociclib in Combination With Aromatase Inhibitor (AI)
PFS was defined as the time from the index date to progression or death, whichever occurred first. Progression of disease was based on scans and blood testing results. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Index date was date of relapse or stage IV disease. Stage IV disease means that the cancer has spread to distant parts of the body. Kaplan-Meier method was used for analysis.
Measured: From index date until the first documentation of disease progression or death or censoring date of 07-Mar-2022 (maximum up to 5.2 years)
Time on Treatment (ToT) for Participants Who Received Palbociclib in Combination With Aromatase Inhibitor (AI)
ToT was defined as date of palbociclib treatment start to date of treatment stop with palbociclib.
Measured: From start date of palbociclib treatment until stop date of palbociclib treatment (maximum up to 5.2 years)

Secondary outcomes (12)

Overall Survival (OS) in Participants Who Received Palbociclib in Combination With AI
OS was defined as the date of metastatic breast cancer diagnosis until death of any cause. Participants were censored for OS by 01-May-2022. Stage IV disease means that the cancer has spread to distant parts of the body.
Measured: From date of metastatic breast cancer diagnosis until death due to any cause or censoring date of 01-May-2022 (approximately 6 years)
Progression-Free Survival (PFS) for Participants Who Received Palbociclib in Combination With Fulvestrant
PFS was defined as the time from the index date to progression or death, whichever occurred first. Progression of disease was based on scans and blood testing results. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Index date was date of relapse or stage IV disease. Stage IV disease means that the cancer has spread to distant parts of the body.
Measured: From index date until the first documentation of disease progression or death or censoring date of 07-Mar-2022 (maximum up to 5.2 years)
Time on Treatment (ToT) for Participants Who Received Palbociclib in Combination With Fulvestrant
ToT is defined as date of palbociclib treatment start to date of treatment stop with palbociclib.
Measured: From start date of study treatment until stop date of treatment (maximum up to 5.2 years)
OS in Participants Who Received Palbociclib in Combination With Fulvestrant
OS was defined as the date of metastatic breast cancer diagnosis until death of any cause. Participants were censored for OS by 01-May-2022. Stage IV disease means that the cancer has spread to distant parts of the body.
Measured: From date of metastatic breast cancer diagnosis until death due to any cause or censoring date of 01-May-2022 (approximately 6 years)
Number of Participants According to First Subsequent Post-Palbociclib Treatment Upon Progression
Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Number of participants as per first subsequent post-palbociclib therapy upon disease progression was described in this outcome measure.
Measured: At progression (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])
Number of Participants According to Type of Metastases
Number of participants according to type of metastases (visceral, non-visceral, both visceral and non-visceral and inoperable locally-advanced breast cancer [ILABC]) is presented in this outcome measure.
Measured: At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])
Number of Participants According to Number of Metastases
Number of participants according to number of metastases (0,1,2,greater than [>] 2) is presented in this outcome measure.
Measured: At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])
Number of Participants According to Location of Metastases
Number of participants according to location of metastases (skin, bone, lung, liver, central nervous system [CNS], other) is presented in this outcome measure. One participant may have more than one location of metastases.
Measured: At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])
Number of Participants Who Underwent Surgery
Number of participants who underwent surgery were described.
Measured: At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])
Number of Participants According to Type of Adjuvant Treatment
Participants who received adjuvant treatment (endocrine therapy, taxane, cyclophosphamide and epirubicin, unknown and other) were described in this outcome measure. One participant may have received more than one type of adjuvant treatment.
Measured: At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])
Number of Participants With De Novo and Recurrent Metastatic Breast Cancer
Participants who had de novo and recurrent metastatic breast cancer were reported in this outcome measure.
Measured: At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])
Median Time From Initial Breast Cancer Diagnosis to Relapse
Median time from initial breast cancer diagnosis (incidence date) to relapse is reported in this outcome measure.
Measured: At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])

Timeline

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

1 Feb 20221 Aug 2022

First posted11 Jul 2022
Study start1 Feb 2022
Primary completion1 Aug 2022
Study completion1 Aug 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: 1,054 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05452798
Sponsor's protocol ID: A5481176
Status last verified: Jul 2023
First submitted: 6 Jul 2022
Last updated: 1 Mar 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

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All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Retrospective Non-interventional Study of Breast Cancer Patients Diagnosed With HR+/HER2- Locally Advanced or Metastatic Breast Cancer Treated With Palbociclib in Denmark
ClinicalTrials.gov ID: NCT05452798
Acronym / sponsor ID: A5481176
Conditions: Breast Cancer
Keywords: Metastatic Breast Cancer, HR+/ HER2-
Study type: Observational
Recruitment status: Completed
Enrolment: 1,054 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 1 Feb 2022 (actual)
Primary completion: 1 Aug 2022 (actual)
Study completion: 1 Aug 2022 (actual)
First posted: 11 Jul 2022 (actual)
Results: Posted 1 Mar 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with HR+/HER2- locally advanced or metastatic breast cancer treated with palbociclib (1st or 2nd line between 01 Jan 2017- 31 Dec 2020).

Key inclusion criteria (4 listed)

Patients with breast cancer (International Statistical Classification of Diseases and Related Health Problems, 10th Revision [ICD-10]: ICD-10 code for patients with breast cancer [DC50])
A diagnosis of HR+/HER2- locally advanced or metastatic breast cancer
Initiated treatment with palbociclib as either 1st or 2nd line treatment between 01 January 2017 and 31 December 2020
Inclusion date: Date of relapse/stage IV disease/progression leading to initiation of palbociclib+AI/progression leading to initiation of palbociclib+fulvestrant

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

Progression-Free Survival (PFS) for Participants Who Received Palbociclib in Combination With Aromatase Inhibitor (AI)
Time frame: From index date until the first documentation of disease progression or death or censoring date of 07-Mar-2022 (maximum up to 5.2 years)
PFS was defined as the time from the index date to progression or death, whichever occurred first. Progression of disease was based on scans and blood testing results. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Index date was date of relapse or stage IV disease. Stage IV disease means that the cancer has spread to distant parts of the body. Kaplan-Meier method was used for analysis.
Time on Treatment (ToT) for Participants Who Received Palbociclib in Combination With Aromatase Inhibitor (AI)
Time frame: From start date of palbociclib treatment until stop date of palbociclib treatment (maximum up to 5.2 years)
ToT was defined as date of palbociclib treatment start to date of treatment stop with palbociclib.

12 secondary outcomes

Overall Survival (OS) in Participants Who Received Palbociclib in Combination With AI
Time frame: From date of metastatic breast cancer diagnosis until death due to any cause or censoring date of 01-May-2022 (approximately 6 years)
Progression-Free Survival (PFS) for Participants Who Received Palbociclib in Combination With Fulvestrant
Time frame: From index date until the first documentation of disease progression or death or censoring date of 07-Mar-2022 (maximum up to 5.2 years)
Time on Treatment (ToT) for Participants Who Received Palbociclib in Combination With Fulvestrant
Time frame: From start date of study treatment until stop date of treatment (maximum up to 5.2 years)
OS in Participants Who Received Palbociclib in Combination With Fulvestrant
Time frame: From date of metastatic breast cancer diagnosis until death due to any cause or censoring date of 01-May-2022 (approximately 6 years)
Number of Participants According to First Subsequent Post-Palbociclib Treatment Upon Progression
Time frame: At progression (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])
Number of Participants According to Type of Metastases
Time frame: At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])
Number of Participants According to Number of Metastases
Time frame: At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])
Number of Participants According to Location of Metastases
Time frame: At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])
Number of Participants Who Underwent Surgery
Time frame: At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])
Number of Participants According to Type of Adjuvant Treatment
Time frame: At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])
Number of Participants With De Novo and Recurrent Metastatic Breast Cancer
Time frame: At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])
Median Time From Initial Breast Cancer Diagnosis to Relapse
Time frame: At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])

Results and safety

Results posted to the registry on 1 Mar 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	1,054	1,054

Primary outcome: Progression-Free Survival (PFS) for Participants Who Received Palbociclib in Combination With Aromatase Inhibitor (AI)

Time frame: From index date until the first documentation of disease progression or death or censoring date of 07-Mar-2022 (maximum up to 5.2 years). Median (Inter-Quartile Range). Unit: Months

Measure	Palbociclib n = 525
Value	27.4 (12.4 to 57.3)

Population analysed: Analysis was performed on participants with HR+/HER2- locally advanced or metastatic BC who initiated treatment with palbociclib in combination with AI between 01 January 2017 and 31 December 2020.

Primary outcome: Time on Treatment (ToT) for Participants Who Received Palbociclib in Combination With Aromatase Inhibitor (AI)

Time frame: From start date of palbociclib treatment until stop date of palbociclib treatment (maximum up to 5.2 years). Median (Inter-Quartile Range). Unit: Months

Measure	Palbociclib n = 525
Value	18.5 (7 to 41.1)

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality: From date of metastatic breast cancer diagnosis until the end of follow-up (approximately 6 years). Data for non-serious adverse events and serious adverse events (SAEs) were not collected and evaluated during the study; hence timeframe is not applicable for non-SAEs and SAEs.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Palbociclib	0 of 0	0 of 0	525 of 1,054

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 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.

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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 Denmark.

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 1 Mar 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 Denmark. 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 1 Mar 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?

Progression-Free Survival (PFS) for Participants Who Received Palbociclib in Combination With Aromatase Inhibitor (AI) (time frame: From index date until the first documentation of disease progression or death or censoring date of 07-Mar-2022 (maximum up to 5.2 years)). 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 NCT05452798.

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 1 Mar 2024.