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Completed

NCT Number: NCT05043506

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

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sankt Josef Hospital Braunau, Braunau am Inn, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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])

Treatment and study plan

Palbociclib + aromatase inhibitor

Drug

Palbociclib + an aromatase inhibitor therapy

Other names: Palbociclib + an aromatase inhibitor therapy

Aromatase Inhibitor

Drug

Aromatase inhibitor monotherapy

Other names: Aromatase inhibitor monotherapy

Primary outcomes

  1. Real-world progression free survival

    Time frame: From treatment line start date to clinician-assessed date of disease progression or date of censoring, assessed up to 59 months

    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 outcomes

  1. Overall survival

    Time frame: From treatment line start date to clinician-assessed date of death or date of censoring, assessed up to 59 months

    Time from the treatment line start to the date of confirmed death, or the date of censoring

  2. Time to first objective tumor response

    Time frame: From treatment line start date to clinician-assessed first date of objective response or date of censoring, assessed up to 59 months

    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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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)

Acronym: EUCHARIS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 14, 2021
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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