European Treatment Patterns and Outcomes Associated With First-Line CDK4/6 Inhibition and Hormonal Therapies (EUCHARIS)

June 24, 2026 updated by: Pfizer

European Treatment Patterns and Outcomes Associated With First-Line CDK4/6 Inhibition and Hormonal Therapies Assessed in a Real-World Non-Interventional Study (EUCHARIS)

A retrospective observational analysis of de-identified data from a multinational medical record review to describe patient characteristics, treatment patterns, and effectiveness of palbociclib + AI as first-line therapy among adult patients with HR+/HER2- advanced breast cancer (ABC) in Europe

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.
1939

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Austria
      • Braunau am Inn, Austria, 5280
        • Sankt Josef Hospital Braunau
      • Krems, Austria, 3500
        • Landesklinikum Krems
      • Sankt Pölten, Austria, 3100
        • Universitaetsklinikum Sankt Poelten
      • Schwaz, Austria, 6130
        • Priv. Doz. OA Dr. Michael Hubalek
  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven
  • Germany
      • Dresden, Germany, 01127
        • Group practice Goehler
      • Frankfurt, Germany, 60389
        • Bethanien Center for Hematology and Oncology
      • Hamburg, Germany, 48415
        • Überörtliche Gemeinschaftspraxis
      • Paderborn, Germany, 33098
        • St. Vincenz-Krankenhaus GmbH
      • Stralsund, Germany, 18439
        • Gynäkologie Kompetenzzentrum Praxis Dr. med. Carsten Hielscher
      • Westerstede, Germany, 26655
        • Medizinische Studiengesellschaft Nord-West GmbH
    • Bavaria
      • Würzburg, Bavaria, Germany, 97080
        • Universitatsklinikum Wurzburg Frauenklinik und Poliklinik
    • Brandenburg
      • Berlin, Brandenburg, Germany, 13597
        • MediOnko-Institut GbR
    • Landkreis Boblingen
      • Sindelfingen, Landkreis Boblingen, Germany, 71065
        • Kreisklinikum Böblingen gGmbH, Frauenklinik Böblingen
    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Germany, 45147
        • Universitätsklinikum Essen
    • Ostprignitz-ruppin
      • Neuruppin, Ostprignitz-ruppin, Germany, 16816
        • Ruppiner Kliniken GmbH
    • Peine
      • Ilsede, Peine, Germany, D-31241
        • Frauenarztpraxis
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55116
        • Institut für Versorgungsforschung GbR
    • Saarland
      • Saarbrücken, Saarland, Germany, 66123
        • Universität des Saarlandes
    • Saxony
      • Emden, Saxony, Germany, 26721
        • Studienzentrum UnterEms
      • Leipzig, Saxony, Germany, 04103
        • Universitatsklinikum Leipzig
  • Spain
      • Albacete, Spain, 02006
        • Complejo Universitario de Albacete
      • Granada, Spain, 18014
        • Hospital Universitario Virgen de las Nieves
      • León, Spain, 24007
        • Complejo Asistencial Universitario de León
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Santander, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
      • Tarragona, Spain, 43003
        • Hospital de Sant Pau i Santa Tecla
      • Valencia, Spain, 46017
        • Hospital Universitario Dr. Peset
    • Andalusia
      • Cadiz, Andalusia, Spain, 11510
        • Hospital Universitario de Puerto Real
    • Barcelona [barcelona]
      • L'Hospitalet de Llobregat, Barcelona [barcelona], Spain, 08908
        • Institut Catalâ Oncologia-L'Hospitalet
    • Bizkaia
      • Bilbao, Bizkaia, Spain, 48013
        • Hospital Universitario de Basurto
    • Cantabria Castilla Y LEON
      • Vigo, Pontevedra, Cantabria Castilla Y LEON, Spain, 36211
        • Complejo Hospitalario Universitario de Vigo. Area Sanitaria de Vigo. Hospital Alvaro Cunqueiro
    • Comunidad de Murcia
      • Murcia, Comunidad de Murcia, Spain, 30008
        • Hospital General Universitario Morales Meseguer
    • Huesca/ Aragon
      • Zaragoza, Huesca/ Aragon, Spain, 50009
        • Hospital San Jorge Huesca
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Puerta de Hierro
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Hospital Universitario Quiron Madrid
    • Madrid/castilla LA Mancha
      • Talavera de La Reina, Toledo, Madrid/castilla LA Mancha, Spain, 45600
        • Hospital nuestra señora del prado de Toledo
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Complejo Hospitalario de Navarra
    • Santiago de Compostela/cantabria
      • Santiago de Compostela, Santiago de Compostela/cantabria, Spain, 15706
        • Hospital Clinico de Santiago de Compostela
    • Sevila
      • Seville, Sevila, Spain, 41013
        • Hospital Universitario Virgen del Rocío
    • Valencia/madrid Castilla LA Mancha
      • Sagunto, Valencia, Valencia/madrid Castilla LA Mancha, Spain, 46520
        • Hospital de Sagunto
  • Sweden
      • Bromma, Sweden, 167 56
        • St Goran Hospital
      • Uppsala, Sweden, 751 85
        • Uppsala University Hospital
      • Örebro, Sweden, 70286
        • Örebro University Hospital
    • Södermanlands LÄN [se-04]
      • Eskilstuna, Södermanlands LÄN [se-04], Sweden, 631 88
        • Mälarsjukhuset
  • Switzerland
      • Baden, Switzerland, 5404
        • Kantonsspital Baden AG
      • Liestal, Switzerland
        • Kantonsspital Baselland
  • United Kingdom
      • Bath, United Kingdom, BA1 3NG
        • Royal United Hospital Bath NHS Trust
      • Blackburn, United Kingdom, BB2 3HH
        • Royal Blackburn Hospital
      • Bournemouth, United Kingdom, BH7 7DW
        • Royal Bournemouth Hospital
      • Cornwall, United Kingdom, TR1 3LJ
        • Royal Cornwall Hospital
      • Nottingham, United Kingdom, GGS 1PB
        • Nottingham University Hospitals NHS Trust
    • Buckinghamshire
      • Buckinghamshire, Buckinghamshire, United Kingdom, HP7 0JD
        • Buckinghamshire Healthcare NHS Trust, Stoke Mandeville Hospital
    • Denbighshire
      • Rhyl, Denbighshire, United Kingdom, LL18 5UJ
        • Glan Clwyd Hospital
    • Edinburgh
      • Waterloo Place, Edinburgh, United Kingdom, EH1 3EG
        • Western General Hospital
    • Glasglow City, Scotland
      • Glasglow, Glasglow City, Scotland, United Kingdom, G12 0YH
        • Beatson West of Scotland Cancer Centre
    • Gwynedd
      • Bangor, Gwynedd, United Kingdom, LL57 2PW
        • Ysbyty Gwynedd Hospital
    • Norfolk
      • Kings Lynn, Norfolk, United Kingdom, PE30 4ET
        • Queen Elizabeth Hospital
    • Scotland
      • Roxburghshire, Scotland, United Kingdom, TD6 9BS
        • Borders General Hospital
      • Stirling, Scotland, United Kingdom, FK9 4SW
        • Forth Valley Royal Hospital
    • Shropshire
      • Shrewsbury, Shropshire, United Kingdom, SY3 8XQ
        • Shrewsbury and Telford Hospital NHS Trust
    • WEST Yorkshire
      • Bradford, WEST Yorkshire, United Kingdom, BD9 6RJ
        • Bradford Teaching Hospitals NHS Foundation Trust
      • Keighley, WEST Yorkshire, United Kingdom, BD20 6TD
        • Airedale NHS Foundation Trust
    • Wales
      • Wrexham, Wales, United Kingdom, LL13 7TD
        • Wrexham Maelor Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with HR+/HER2- advanced breast cancer treated with palbociclib + an aromatase inhibitor or an aromatase inhibitor alone between January 1, 2010 to July 31, 2020

Description

Inclusion Criteria:

  • Is male or female
  • Has histologically or cytologically confirmed breast cancer diagnosis (HR+/HER2- breast cancer)
  • Has received a diagnosis of locally advanced breast cancer not amenable to curative radiation or surgical cure or of metastatic breast cancer (i.e., advanced breast cancer [ABC]); diagnosis may be de novo (initial diagnosis at ABC stage) or recurrent from earlier-stage disease (initial diagnosis of earlier-stage disease with subsequent progression to advanced disease)
  • Has initiated a required first-line therapy of interest: Palbociclib plus AI as first-line therapy for ABC between September 1, 2016, and July 31, 2020, or AI monotherapy as first-line therapy for ABC between January 1, 2010,, and July 31, 2020
  • Was aged 18 years or older at the time of diagnosis of ABC
  • Is living or deceased at the time of record abstraction
  • Has a complete medical record, covering treatment for ABC, including any transfer record from other facilities (if applicable) that is available to the abstractor for data abstraction

Exclusion Criteria:

  • The patient's first treatment after ABC diagnosis was chemotherapy (including induction chemotherapy)
  • The patient has evidence of other active malignant neoplasms within 3 years (except nonmelanoma skin cancer or carcinoma in situ) prior to diagnosis of ABC; patients diagnosed with second primary cancer after ABC diagnosis will not be excluded
  • The patient has evidence of prior treatment with any CDK4/6 inhibitor (i.e. palbociclib, abemaciclib, ribociclib) in the early-stage breast cancer setting or treatment with abemaciclib or ribociclib in the ABC setting
  • The patient has participated in a clinical trial related to treatment of ABC (including after first-line therapy [i.e., palbociclib plus AI or AI monotherapy])

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Palbociclib + aromatase inhibitor
Adult patients with advanced breast cancer patients who initiated Palbociclib + an aromatase inhibitor as first line therapy between September 1, 2016, and July 31, 2020.
Drug: Palbociclib + aromatase inhibitor
Palbociclib + an aromatase inhibitor therapy
Other Names:
  • Palbociclib + an aromatase inhibitor therapy
Aromatase inhibitor
Adult patients with advanced breast cancer patients who initiated an aromatase inhibitor as first line therapy between January 1, 2010,, and July 31, 2020
Drug: Aromatase inhibitor
Aromatase inhibitor monotherapy
Other Names:
  • Aromatase inhibitor monotherapy

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
Real-world progression free survival
Time Frame: From treatment line start date to clinician-assessed date of disease progression or date of censoring, assessed up to 59 months
Total time from the treatment line start date to the date of disease progression confirmed by clinician assessment or the date of censoring, as measured in months
From treatment line start date to clinician-assessed date of disease progression or date of censoring, assessed up to 59 months

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
Time Frame: From treatment line start date to clinician-assessed date of death or date of censoring, assessed up to 59 months
Time from the treatment line start to the date of confirmed death, or the date of censoring
From treatment line start date to clinician-assessed date of death or date of censoring, assessed up to 59 months
Time to first objective tumor response
Time Frame: From treatment line start date to clinician-assessed first date of objective response or date of censoring, assessed up to 59 months
Time from the date of treatment line start to the first date of clinician-assessed objective response, or the date of censoring, measured in months
From treatment line start date to clinician-assessed first date of objective response or date of censoring, assessed up to 59 months

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 8, 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.
November 2, 2023

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.
November 2, 2023

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).
September 7, 2021

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.
September 7, 2021

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.
September 14, 2021

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.
June 30, 2026

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.
June 24, 2026

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.
May 1, 2026

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.
  • A5481170
  • EUCHARIS (Other Identifier: Alias Study Number)

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings