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

CompletedN/A

Sponsor: Pfizer

Conditions: Metastatic Breast Cancer

Interventions: Palbociclib + aromatase inhibitor, Aromatase inhibitor

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

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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

Locations (64)

Braunau am Inn, Austria
Krems, Austria
Sankt Pölten, Austria
Schwaz, Austria
Leuven, Belgium
Würzburg, Bavaria, Germany
Berlin, Brandenburg, Germany
Sindelfingen, Landkreis Boblingen, Germany
Essen, North Rhine-Westphalia, Germany
Neuruppin, Ostprignitz-ruppin, Germany
Ilsede, Peine, Germany
Mainz, Rhineland-Palatinate, Germany
Saarbrücken, Saarland, Germany
Emden, Saxony, Germany
Leipzig, Saxony, Germany
Dresden, Germany
Frankfurt, Germany
Hamburg, Germany
Paderborn, Germany
Stralsund, Germany
Westerstede, Germany
Cadiz, Andalusia, Spain
L'Hospitalet de Llobregat, Barcelona [barcelona], Spain
Bilbao, Bizkaia, Spain
Vigo, Pontevedra, Cantabria Castilla Y LEON, Spain
Murcia, Comunidad de Murcia, Spain
Zaragoza, Huesca/ Aragon, Spain
Majadahonda, Madrid, Spain
Pozuelo de Alarcón, Madrid, Spain
Talavera de La Reina, Toledo, Madrid/castilla LA Mancha, Spain
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