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

July 13, 2023 updated by: Pfizer
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 in combination treatment

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1054

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Danish Breast Cancer Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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).

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • There are no exclusion criteria for this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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)
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.
From start date of palbociclib treatment until stop date of palbociclib treatment (maximum up to 5.2 years)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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.
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)
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.
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)
ToT is defined as date of palbociclib treatment start to date of treatment stop with palbociclib.
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)
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.
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])
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.
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 type of metastases (visceral, non-visceral, both visceral and non-visceral and inoperable locally-advanced breast cancer [ILABC]) is presented in this outcome measure.
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 number of metastases (0,1,2,greater than [>] 2) is presented in this outcome measure.
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 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.
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 who underwent surgery were described.
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])
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.
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])
Participants who had de novo and recurrent metastatic breast cancer were reported in this outcome measure.
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])
Median time from initial breast cancer diagnosis (incidence date) to relapse is reported in this outcome measure.
At Baseline (anytime between 01 January 2017 and 31 December 2020 [maximum up to 4 years])

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A5481176

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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