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

Metastatic Breast Cancer Clinical Trial

— EUCHARIS  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05043506
• Other study ID #: A5481170
• Secondary ID: EUCHARIS
• Status: Completed
• Start date: February 8, 2022
• Est. completion date: November 2, 2023

Study information

• Verified date: March 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1939
• Est. completion date: November 2, 2023
• Est. primary completion date: November 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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])

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Palbociclib + aromatase inhibitor
Palbociclib + an aromatase inhibitor therapy
• Aromatase inhibitor
Aromatase inhibitor monotherapy

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Austria,  Belgium,  Germany,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival	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
Secondary	Time to first objective tumor response	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

External Links

•   To obtain contact information for a study center near you, click here.