European Treatment Patterns and Outcomes Associated With First-Line CDK4/6 Inhibition and Hormonal Therapies Assessed in a Real-World Non-Interventional Study (EUCHARIS)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 1,939
- Locations
- 114
- Primary Endpoint
- Real-world progression free survival
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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])
Arms & Interventions
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.
Intervention: Palbociclib + aromatase inhibitor (Drug)
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
Intervention: Aromatase inhibitor (Drug)
Outcomes
Primary Outcomes
Real-world progression free survival
Time Frame: 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
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
- Overall survival(Time from treatment line start date to clinician assessed date of death, or 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)
- Overall survival(From treatment line start date to clinician-assessed date of death or date of censoring, assessed up to 59 months)
- Time to first objective tumor response(From treatment line start date to clinician-assessed first date of objective response or date of censoring, assessed up to 59 months)