European Treatment Patterns and Outcomes Associated With First-Line CDK4/6 Inhibition and Hormonal Therapies
- Conditions
- Metastatic Breast Cancer
- Interventions
- Drug: Palbociclib + aromatase inhibitorDrug: Aromatase inhibitor
- Registration Number
- NCT05043506
- Lead Sponsor
- Pfizer
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1939
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Palbociclib + aromatase inhibitor 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 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
- Primary Outcome Measures
Name Time Method Real-world progression free survival 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
- Secondary Outcome Measures
Name Time Method Overall survival 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 to first objective tumor response 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
Trial Locations
- Locations (64)
Örebro University Hospital
🇸🇪Örebro, Sweden
Medizinische Studiengesellschaft NORD-WEST GmbH
🇩🇪Westerstede, Germany
Ruppiner Kliniken GmbH
🇩🇪Neuruppin, Ostprignitz-ruppin, Germany
Kantonsspital Baselland
🇨🇭Liestal, Switzerland
Complejo Universitario de Albacete
🇪🇸Albacete, Spain
Western General Hospital
🇬🇧Waterloo Place, Edinburgh, United Kingdom
Hospital Universitario Quiron Madrid
🇪🇸Pozuelo de Alarcon, Madrid, Spain
Gynäkologie Kompetenzzentrum Praxis Dr. med. Carsten Hielscher
🇩🇪Stralsund, Germany
Royal Bournemouth Hospital
🇬🇧Bournemouth, United Kingdom
Glan Clwyd Hospital
🇬🇧Rhyl, Denbighshire, United Kingdom
Airedale NHS Foundation Trust
🇬🇧Keighley, WEST Yorkshire, United Kingdom
Hospital Universitario Virgen Del Rocio
🇪🇸Sevilla, Sevila, Spain
Universitätsklinikum Leipzig
🇩🇪Leipzig, Saxony, Germany
Hospital Universitario de Puerto Real
🇪🇸Cádiz, Andalucía, Spain
St Goran Hospital
🇸🇪Bromma, Sweden
Hospital de Sagunto
🇪🇸Sagunto, Valencia, Valencia/madrid Castilla LA Mancha, Spain
UZ Leuven
🇧🇪Leuven, Belgium
Hospital General Universitario Morales Meseguer
🇪🇸Murcia, Comunidad DE Murcia, Spain
Mälarsjukhuset
🇸🇪Eskilstuna, Södermanlands LÄN [se-04], Sweden
Complejo Hospitalario Universitario de Vigo. Area Sanitaria de Vigo. Hospital Alvaro Cunqueiro
🇪🇸Vigo, Pontevedra, Cantabria Castilla Y LEON, Spain
Studienzentrum UnterEms
🇩🇪Emden, Saxony, Germany
St. Vincenz-Krankenhaus GmbH
🇩🇪Paderborn, Germany
Hospital Universitario Virgen de Las Nieves
🇪🇸Granada, Spain
Bethanien Center for Hematology and Oncology
🇩🇪Frankfurt, Germany
Complejo Asistencial Universitario de Leon
🇪🇸Leon, Spain
Sankt Josef Hospital Braunau
🇦🇹Braunau, Austria
Hospital Puerta de Hierro
🇪🇸Majadahonda, Madrid, Spain
Frauenarztpraxis
🇩🇪Ilsede, Peine, Germany
Group practice Goehler
🇩🇪Dresden, Germany
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, United Kingdom
Ysbyty Gwynedd Hospital
🇬🇧Bangor, Gwynedd, United Kingdom
Universität des Saarlandes
🇩🇪Saarbrücken, Saarland, Germany
Universitatsklinikum Essen
🇩🇪Essen, North Rhine-westphalia, Germany
Royal United Hospital Bath NHS Trust
🇬🇧Bath, United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust
🇬🇧Bradford, WEST Yorkshire, United Kingdom
Royal Blackburn Hospital
🇬🇧Blackburn, United Kingdom
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
Wrexham Maelor Hospital
🇬🇧Wrexham, Wales, United Kingdom
Universitaetsklinikum Sankt Poelten
🇦🇹Sankt Poelten, Austria
Landesklinikum Krems
🇦🇹Krems, Austria
Priv. Doz. OA Dr. Michael Hubalek
🇦🇹Schwaz, Austria
Universitätsklinikum Würzburg Frauenklinik und Poliklinik
🇩🇪Würzburg, Bavaria, Germany
Kreisklinikum Böblingen gGmbH, Frauenklinik Böblingen
🇩🇪Sindelfingen, Landkreis Boblingen, Germany
Institut für Versorgungsforschung GbR
🇩🇪Mainz, Rhineland-palatinate, Germany
Hospital Universitario de Basurto
🇪🇸Bilbao, Bizkaia, Spain
Überörtliche Gemeinschaftspraxis
🇩🇪Hamburg, Germany
Institut Catalâ Oncologia-L'Hospitalet
🇪🇸Hospitalet de Llobregat, Barcelona [barcelona], Spain
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital San Jorge Huesca
🇪🇸Zaragoza, Huesca/ Aragon, Spain
Hospital nuestra señora del prado de Toledo
🇪🇸Talavera De La Reina, Toledo, Madrid/castilla LA Mancha, Spain
Hospital Clínico de Santiago de Compostela
🇪🇸Santiago de Compostela, Santiago DE Compostela/cantabria, Spain
Uppsala University Hospital
🇸🇪Uppsala, Sweden
Beatson West of Scotland Cancer Centre
🇬🇧Glasglow, Glasglow City, Scotland, United Kingdom
Borders General Hospital
🇬🇧Roxburghshire, Scotland, United Kingdom
Shrewsbury and Telford Hospital NHS Trust
🇬🇧Shrewsbury, Shropshire, United Kingdom
Buckinghamshire Healthcare NHS Trust, Stoke Mandeville Hospital
🇬🇧Buckinghamshire, United Kingdom
Royal Cornwall Hospital
🇬🇧Cornwall, United Kingdom
MediOnko-Institut GbR
🇩🇪Berlin, Brandenburg, Germany
Kantonsspital Baden AG
🇨🇭Baden, Switzerland
Queen Elizabeth Hospital
🇬🇧King's Lynn, Norfolk, United Kingdom
Forth Valley Royal Hospital
🇬🇧Stirling, Scotland, United Kingdom