Clinical trial NCT05043506: European Treatment Patterns and Outcomes Associated With First-Line CDK4/6 Inhibition and Hormonal Therapies
Official title: European Treatment Patterns and Outcomes Associated With First-Line CDK4/6 Inhibition and Hormonal Therapies Assessed in a Real-World Non-Interventional Study (EUCHARIS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Breast Cancer
Keywords: breast cancer
Palbociclib
Real-world data
CDK4/6
effectiveness
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-09-14
Enrollment: 1939
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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


Eligibility criteria: 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 \[i.e., palbociclib plus AI or AI monotherapy\])

Primary outcomes:
measure: Real-world progression free survival
timeFrame: Time from treatment line start date to clinician assessed date of disease progression, date of death, or date of censoring
Secondary outcomes:
measure: Overall survival
timeFrame: Time from treatment line start date to clinician assessed date of death, or date of censoring
measure: Time to first objective tumor response
timeFrame: Time from treatment line start date to clinician-assessed first date of objective response or date of censoring
Other outcomes:
Locations:
city: Braunau
country: Austria
facility: Sankt Josef Hospital Braunau
city: Krems
country: Austria
facility: Landesklinikum Krems
city: Sankt Poelten
country: Austria
facility: Universitaetsklinikum Sankt Poelten
city: Schwaz
country: Austria
facility: Priv. Doz. OA Dr. Michael Hubalek
city: Leuven
country: Belgium
facility: UZ Leuven
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg Frauenklinik und Poliklinik
state: Bavaria
city: Berlin
country: Germany
facility: MediOnko-Institut GbR
state: Brandenburg
city: Sindelfingen
country: Germany
facility: Kreisklinikum Böblingen gGmbH, Frauenklinik Böblingen
state: Landkreis Boblingen
city: Essen
country: Germany
facility: Universitatsklinikum Essen
state: North Rhine-westphalia
city: Neuruppin
country: Germany
facility: Ruppiner Kliniken GmbH
state: Ostprignitz-ruppin
city: Ilsede
country: Germany
facility: Frauenarztpraxis
state: Peine
city: Mainz
country: Germany
facility: Institut für Versorgungsforschung GbR
state: Rhineland-palatinate
city: Saarbrücken
country: Germany
facility: Universität des Saarlandes
state: Saarland
city: Emden
country: Germany
facility: Studienzentrum UnterEms
state: Saxony
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
state: Saxony
city: Dresden
country: Germany
facility: Group practice Goehler
city: Frankfurt
country: Germany
facility: Bethanien Center for Hematology and Oncology
city: Hamburg
country: Germany
facility: Überörtliche Gemeinschaftspraxis
city: Paderborn
country: Germany
facility: St. Vincenz-Krankenhaus GmbH
city: Stralsund
country: Germany
facility: Gynäkologie Kompetenzzentrum Praxis Dr. med. Carsten Hielscher
city: Westerstede
country: Germany
facility: Medizinische Studiengesellschaft NORD-WEST GmbH
city: Cádiz
country: Spain
facility: Hospital Universitario de Puerto Real
state: Andalucía
city: Hospitalet de Llobregat
country: Spain
facility: Institut Catalâ Oncologia-L'Hospitalet
state: Barcelona [barcelona]
city: Bilbao
country: Spain
facility: Hospital Universitario de Basurto
state: Bizkaia
city: Vigo, Pontevedra
country: Spain
facility: Complejo Hospitalario Universitario de Vigo. Area Sanitaria de Vigo. Hospital Alvaro Cunqueiro
state: Cantabria Castilla Y LEON
city: Murcia
country: Spain
facility: Hospital General Universitario Morales Meseguer
state: Comunidad DE Murcia
city: Zaragoza
country: Spain
facility: Hospital San Jorge Huesca
state: Huesca/ Aragon
city: Talavera De La Reina, Toledo
country: Spain
facility: Hospital nuestra señora del prado de Toledo
state: Madrid/castilla LA Mancha
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro
state: Madrid
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Universitario Quiron Madrid
state: Madrid
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico de Santiago de Compostela
state: Santiago DE Compostela/cantabria
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
state: Sevila
city: Sagunto, Valencia
country: Spain
facility: Hospital de Sagunto
state: Valencia/madrid Castilla LA Mancha
city: Albacete
country: Spain
facility: Complejo Universitario de Albacete
city: Granada
country: Spain
facility: Hospital Universitario Virgen de Las Nieves
city: Leon
country: Spain
facility: Complejo Asistencial Universitario de Leon
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Tarragona
country: Spain
facility: Hospital de Sant Pau i Santa Tecla
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset
city: Eskilstuna
country: Sweden
facility: Mälarsjukhuset
state: Södermanlands LÄN [se-04]
city: Bromma
country: Sweden
facility: St Goran Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Örebro
country: Sweden
facility: Örebro University Hospital
city: Baden
country: Switzerland
facility: Kantonsspital Baden AG
city: Liestal
country: Switzerland
facility: Kantonsspital Baselland
city: Rhyl
country: United Kingdom
facility: Glan Clwyd Hospital
state: Denbighshire
city: Waterloo Place
country: United Kingdom
facility: Western General Hospital
state: Edinburgh
city: Glasglow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
state: Glasglow City, Scotland
city: Bangor
country: United Kingdom
facility: Ysbyty Gwynedd Hospital
state: Gwynedd
city: King's Lynn
country: United Kingdom
facility: Queen Elizabeth Hospital
state: Norfolk
city: Roxburghshire
country: United Kingdom
facility: Borders General Hospital
state: Scotland
city: Stirling
country: United Kingdom
facility: Forth Valley Royal Hospital
state: Scotland
city: Shrewsbury
country: United Kingdom
facility: Shrewsbury and Telford Hospital NHS Trust
state: Shropshire
city: Wrexham
country: United Kingdom
facility: Wrexham Maelor Hospital
state: Wales
city: Bradford
country: United Kingdom
facility: Bradford Teaching Hospitals NHS Foundation Trust
state: WEST Yorkshire
city: Keighley
country: United Kingdom
facility: Airedale NHS Foundation Trust
state: WEST Yorkshire
city: Bath
country: United Kingdom
facility: Royal United Hospital Bath NHS Trust
city: Blackburn
country: United Kingdom
facility: Royal Blackburn Hospital
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: Buckinghamshire
country: United Kingdom
facility: Buckinghamshire Healthcare NHS Trust, Stoke Mandeville Hospital
city: Cornwall
country: United Kingdom
facility: Royal Cornwall Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: