European Treatment Patterns and Outcomes Associated With First-Line CDK4/6 Inhibition and Hormonal Therapies
EUCHARIS
2 other identifiers
observational
1,939
7 countries
64
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2022
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2021
CompletedFirst Posted
Study publicly available on registry
September 14, 2021
CompletedStudy Start
First participant enrolled
February 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 2, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 2, 2023
CompletedMarch 27, 2024
March 1, 2024
1.7 years
September 7, 2021
March 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Real-world progression free survival
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 Outcomes (2)
Overall survival
Time from treatment line start date to clinician assessed date of death, or date of censoring
Time to first objective tumor response
Time from treatment line start date to clinician-assessed first date of objective response or date of censoring
Study Arms (2)
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.
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
Interventions
Palbociclib + an aromatase inhibitor therapy
Aromatase inhibitor monotherapy
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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 \[i.e., palbociclib plus AI or AI monotherapy\])
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (64)
Sankt Josef Hospital Braunau
Braunau am Inn, 5280, Austria
Landesklinikum Krems
Krems, 3500, Austria
Universitaetsklinikum Sankt Poelten
Sankt Pölten, 3100, Austria
Priv. Doz. OA Dr. Michael Hubalek
Schwaz, 6130, Austria
UZ Leuven
Leuven, 3000, Belgium
Universitätsklinikum Würzburg Frauenklinik und Poliklinik
Würzburg, Bavaria, 97080, Germany
MediOnko-Institut GbR
Berlin, Brandenburg, 13597, Germany
Kreisklinikum Böblingen gGmbH, Frauenklinik Böblingen
Sindelfingen, Landkreis Boblingen, 71065, Germany
Universitatsklinikum Essen
Essen, North Rhine-Westphalia, 45147, Germany
Ruppiner Kliniken GmbH
Neuruppin, Ostprignitz-ruppin, 16816, Germany
Frauenarztpraxis
Ilsede, Peine, D-31241, Germany
Institut für Versorgungsforschung GbR
Mainz, Rhineland-Palatinate, 55116, Germany
Universität des Saarlandes
Saarbrücken, Saarland, 66123, Germany
Studienzentrum UnterEms
Emden, Saxony, 26721, Germany
Universitätsklinikum Leipzig
Leipzig, Saxony, 04103, Germany
Group practice Goehler
Dresden, 01127, Germany
Bethanien Center for Hematology and Oncology
Frankfurt, 60389, Germany
Überörtliche Gemeinschaftspraxis
Hamburg, 48415, Germany
St. Vincenz-Krankenhaus GmbH
Paderborn, 33098, Germany
Gynäkologie Kompetenzzentrum Praxis Dr. med. Carsten Hielscher
Stralsund, 18439, Germany
Medizinische Studiengesellschaft NORD-WEST GmbH
Westerstede, 26655, Germany
Hospital Universitario de Puerto Real
Cadiz, Andalusia, 11510, Spain
Institut Catalâ Oncologia-L'Hospitalet
L'Hospitalet de Llobregat, Barcelona [barcelona], 08908, Spain
Hospital Universitario de Basurto
Bilbao, Bizkaia, 48013, Spain
Complejo Hospitalario Universitario de Vigo. Area Sanitaria de Vigo. Hospital Alvaro Cunqueiro
Vigo, Pontevedra, Cantabria Castilla Y LEON, 36211, Spain
Hospital General Universitario Morales Meseguer
Murcia, Comunidad de Murcia, 30008, Spain
Hospital San Jorge Huesca
Zaragoza, Huesca/ Aragon, 50009, Spain
Hospital Puerta de Hierro
Majadahonda, Madrid, 28222, Spain
Hospital Universitario Quiron Madrid
Pozuelo de Alarcón, Madrid, 28223, Spain
Hospital nuestra señora del prado de Toledo
Talavera de La Reina, Toledo, Madrid/castilla LA Mancha, 45600, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Clínico de Santiago de Compostela
Santiago de Compostela, Santiago de Compostela/cantabria, 15706, Spain
Hospital Universitario Virgen Del Rocio
Seville, Sevila, 41013, Spain
Hospital de Sagunto
Sagunto, Valencia, Valencia/madrid Castilla LA Mancha, 46520, Spain
Complejo Universitario de Albacete
Albacete, 02006, Spain
Hospital Universitario Virgen de Las Nieves
Granada, 18014, Spain
Complejo Asistencial Universitario de Leon
León, 24007, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario Marques de Valdecilla
Santander, 39008, Spain
Hospital de Sant Pau i Santa Tecla
Tarragona, 43003, Spain
Hospital Universitario Dr. Peset
Valencia, 46017, Spain
Mälarsjukhuset
Eskilstuna, Södermanlands LÄN [se-04], 631 88, Sweden
St Goran Hospital
Bromma, 167 56, Sweden
Örebro University Hospital
Örebro, 70286, Sweden
Uppsala University Hospital
Uppsala, 751 85, Sweden
Kantonsspital Baden AG
Baden, 5404, Switzerland
Kantonsspital Baselland
Liestal, Switzerland
Buckinghamshire Healthcare NHS Trust, Stoke Mandeville Hospital
Buckinghamshire, Buckinghamshire, HP7 0JD, United Kingdom
Glan Clwyd Hospital
Rhyl, Denbighshire, LL18 5UJ, United Kingdom
Western General Hospital
Waterloo Place, Edinburgh, EH1 3EG, United Kingdom
Beatson West of Scotland Cancer Centre
Glasglow, Glasglow City, Scotland, G12 0YH, United Kingdom
Ysbyty Gwynedd Hospital
Bangor, Gwynedd, LL57 2PW, United Kingdom
Queen Elizabeth Hospital
Kings Lynn, Norfolk, PE30 4ET, United Kingdom
Borders General Hospital
Roxburghshire, Scotland, TD6 9BS, United Kingdom
Forth Valley Royal Hospital
Stirling, Scotland, FK9 4SW, United Kingdom
Shrewsbury and Telford Hospital NHS Trust
Shrewsbury, Shropshire, SY3 8XQ, United Kingdom
Wrexham Maelor Hospital
Wrexham, Wales, LL13 7TD, United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, WEST Yorkshire, BD9 6RJ, United Kingdom
Airedale NHS Foundation Trust
Keighley, WEST Yorkshire, BD20 6TD, United Kingdom
Royal United Hospital Bath NHS Trust
Bath, BA1 3NG, United Kingdom
Royal Blackburn Hospital
Blackburn, BB2 3HH, United Kingdom
Royal Bournemouth Hospital
Bournemouth, BH7 7DW, United Kingdom
Royal Cornwall Hospital
Cornwall, TR1 3LJ, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, GGS 1PB, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2021
First Posted
September 14, 2021
Study Start
February 8, 2022
Primary Completion
November 2, 2023
Study Completion
November 2, 2023
Last Updated
March 27, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share
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.