Breast Cancer Clinical Trial

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

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

View Eligibility Criteria

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])

Study is for people with:

Breast Cancer

Estimated Enrollment:

2400

Study ID:

NCT05043506

Recruitment Status:

Not yet recruiting

Sponsor:

Pfizer

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There is 1 Location for this study

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Pfizer
New York New York, 10017, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

2400

Study ID:

NCT05043506

Recruitment Status:

Not yet recruiting

Sponsor:


Pfizer

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