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

March 25, 2024 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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

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 Locations

  • Austria
      • Braunau, Austria, 5280
        • Sankt Josef Hospital Braunau
      • Krems, Austria, 3500
        • Landesklinikum Krems
      • Sankt Poelten, 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
        • Universitatsklinikum 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
        • Universitätsklinikum Leipzig
  • Spain
      • Albacete, Spain, 02006
        • Complejo Universitario de Albacete
      • Granada, Spain, 18014
        • Hospital Universitario Virgen de las Nieves
      • Leon, 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
    • Andalucía
      • Cádiz, Andalucía, Spain, 11510
        • Hospital Universitario de Puerto Real
    • Barcelona [barcelona]
      • 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 Alarcon, 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
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Complejo Hospitalario de Navarra
    • Santiago DE Compostela/cantabria
      • Santiago de Compostela, Santiago DE Compostela/cantabria, Spain, 15706
        • Hospital Clínico de Santiago de Compostela
    • Sevila
      • Sevilla, Sevila, Spain, 41013
        • Hospital Universitario Virgen del Rocio
    • 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
        • Orebro 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
      • Buckinghamshire, United Kingdom, HP7 0JD
        • Buckinghamshire Healthcare NHS Trust, Stoke Mandeville Hospital
      • Cornwall, United Kingdom, TR1 3LJ
        • Royal Cornwall Hospital
      • Nottingham, United Kingdom, GGS 1PB
        • Nottingham University Hospitals NHS Trust
    • 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
      • King's 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

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
Intervention / Treatment
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

Outcome Measure
Measure Description
Time Frame
Real-world progression free survival
Time Frame: Time from treatment line start date to clinician assessed date of disease progression, date of death, or date of censoring
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
Time from treatment line start date to clinician assessed date of disease progression, date of death, or date of censoring

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Time from treatment line start date to clinician assessed date of death, or date of censoring
Time from the treatment line start to the date of confirmed death, or the date of censoring
Time from treatment line start date to clinician assessed date of death, or date of censoring
Time to first objective tumor response
Time Frame: Time from treatment line start date to clinician-assessed first date of objective response or date of censoring
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
Time from treatment line start date to clinician-assessed first date of objective response or date of censoring

Collaborators and Investigators

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

Sponsor

Pfizer

Investigators

  • 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)

February 8, 2022

Primary Completion (Actual)

November 2, 2023

Study Completion (Actual)

November 2, 2023

Study Registration Dates

First Submitted

September 7, 2021

First Submitted That Met QC Criteria

September 7, 2021

First Posted (Actual)

September 14, 2021

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

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