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

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: Palbociclib + aromatase inhibitor; Drug: 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

Study Timeline

• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-09-07
• Study First Posted: 2021-09-14
• Study Start: 2022-02-08
• Primary Completion: 2023-11-02
• Study Completion: 2023-11-02
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1939

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])

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)

Sankt Josef Hospital Braunau; 🇦🇹 Braunau, Austria

Landesklinikum Krems; 🇦🇹 Krems, Austria

Universitaetsklinikum Sankt Poelten; 🇦🇹 Sankt Poelten, 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

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