European Treatment Patterns and Outcomes Associated With First-Line CDK4/6 Inhibition and Hormonal Therapies
NCT ID: NCT05043506
Last Updated: 2024-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1939 participants
OBSERVATIONAL
2022-02-08
2023-11-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
Palbociclib + aromatase inhibitor
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
Aromatase inhibitor
Aromatase inhibitor monotherapy
Interventions
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Palbociclib + aromatase inhibitor
Palbociclib + an aromatase inhibitor therapy
Aromatase inhibitor
Aromatase inhibitor monotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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 \[i.e., palbociclib plus AI or AI monotherapy\])
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Sankt Josef Hospital Braunau
Braunau am Inn, , Austria
Landesklinikum Krems
Krems, , Austria
Universitaetsklinikum Sankt Poelten
Sankt Pölten, , Austria
Priv. Doz. OA Dr. Michael Hubalek
Schwaz, , Austria
UZ Leuven
Leuven, , Belgium
Universitätsklinikum Würzburg Frauenklinik und Poliklinik
Würzburg, Bavaria, Germany
MediOnko-Institut GbR
Berlin, Brandenburg, Germany
Kreisklinikum Böblingen gGmbH, Frauenklinik Böblingen
Sindelfingen, Landkreis Boblingen, Germany
Universitatsklinikum Essen
Essen, North Rhine-Westphalia, Germany
Ruppiner Kliniken GmbH
Neuruppin, Ostprignitz-ruppin, Germany
Frauenarztpraxis
Ilsede, Peine, Germany
Institut für Versorgungsforschung GbR
Mainz, Rhineland-Palatinate, Germany
Universität des Saarlandes
Saarbrücken, Saarland, Germany
Studienzentrum UnterEms
Emden, Saxony, Germany
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany
Group practice Goehler
Dresden, , Germany
Bethanien Center for Hematology and Oncology
Frankfurt, , Germany
Überörtliche Gemeinschaftspraxis
Hamburg, , Germany
St. Vincenz-Krankenhaus GmbH
Paderborn, , Germany
Gynäkologie Kompetenzzentrum Praxis Dr. med. Carsten Hielscher
Stralsund, , Germany
Medizinische Studiengesellschaft NORD-WEST GmbH
Westerstede, , Germany
Hospital Universitario de Puerto Real
Cadiz, Andalusia, Spain
Institut Catalâ Oncologia-L'Hospitalet
L'Hospitalet de Llobregat, Barcelona [barcelona], Spain
Hospital Universitario de Basurto
Bilbao, Bizkaia, Spain
Complejo Hospitalario Universitario de Vigo. Area Sanitaria de Vigo. Hospital Alvaro Cunqueiro
Vigo, Pontevedra, Cantabria Castilla Y LEON, Spain
Hospital General Universitario Morales Meseguer
Murcia, Comunidad de Murcia, Spain
Hospital San Jorge Huesca
Zaragoza, Huesca/ Aragon, Spain
Hospital Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital Universitario Quiron Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital nuestra señora del prado de Toledo
Talavera de La Reina, Toledo, Madrid/castilla LA Mancha, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Hospital Clínico de Santiago de Compostela
Santiago de Compostela, Santiago de Compostela/cantabria, Spain
Hospital Universitario Virgen Del Rocio
Seville, Sevila, Spain
Hospital de Sagunto
Sagunto, Valencia, Valencia/madrid Castilla LA Mancha, Spain
Complejo Universitario de Albacete
Albacete, , Spain
Hospital Universitario Virgen de Las Nieves
Granada, , Spain
Complejo Asistencial Universitario de Leon
León, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
Hospital de Sant Pau i Santa Tecla
Tarragona, , Spain
Hospital Universitario Dr. Peset
Valencia, , Spain
Mälarsjukhuset
Eskilstuna, Södermanlands LÄN [se-04], Sweden
St Goran Hospital
Bromma, , Sweden
Örebro University Hospital
Örebro, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
Kantonsspital Baden AG
Baden, , Switzerland
Kantonsspital Baselland
Liestal, , Switzerland
Buckinghamshire Healthcare NHS Trust, Stoke Mandeville Hospital
Buckinghamshire, Buckinghamshire, United Kingdom
Glan Clwyd Hospital
Rhyl, Denbighshire, United Kingdom
Western General Hospital
Waterloo Place, Edinburgh, United Kingdom
Beatson West of Scotland Cancer Centre
Glasglow, Glasglow City, Scotland, United Kingdom
Ysbyty Gwynedd Hospital
Bangor, Gwynedd, United Kingdom
Queen Elizabeth Hospital
Kings Lynn, Norfolk, United Kingdom
Borders General Hospital
Roxburghshire, Scotland, United Kingdom
Forth Valley Royal Hospital
Stirling, Scotland, United Kingdom
Shrewsbury and Telford Hospital NHS Trust
Shrewsbury, Shropshire, United Kingdom
Wrexham Maelor Hospital
Wrexham, Wales, United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, WEST Yorkshire, United Kingdom
Airedale NHS Foundation Trust
Keighley, WEST Yorkshire, United Kingdom
Royal United Hospital Bath NHS Trust
Bath, , United Kingdom
Royal Blackburn Hospital
Blackburn, , United Kingdom
Royal Bournemouth Hospital
Bournemouth, , United Kingdom
Royal Cornwall Hospital
Cornwall, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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EUCHARIS
Identifier Type: OTHER
Identifier Source: secondary_id
A5481170
Identifier Type: -
Identifier Source: org_study_id
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