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

Pfizer

Status: Completed

Conditions: Metastatic Breast Cancer

Treatments: Drug: Aromatase inhibitor; Drug: Palbociclib + aromatase inhibitor

Study type: Observational

Funder types: Industry

Identifiers

NCT05043506

EUCHARIS (Other Identifier)

A5481170

Details and patient eligibility

About

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

Enrollment: 1,939 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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])

Trial design

1,939 participants in 2 patient groups

Palbociclib + aromatase inhibitor

Description:

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.

Treatment:

Drug: Palbociclib + aromatase inhibitor

Aromatase inhibitor

Description:

Adult patients with advanced breast cancer patients who initiated an aromatase inhibitor as first line therapy between January 1, 2010,, and July 31, 2020

Treatment:

Drug: Aromatase inhibitor