Metastatic Breast Cancer
Conditions
Keywords
breast cancer, Palbociclib, Real-world data, CDK4/6, effectiveness
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
Interventions
Palbociclib + an aromatase inhibitor therapy
DRUGAromatase inhibitor
Aromatase inhibitor monotherapy
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 \[i.e., palbociclib plus AI or AI monotherapy\])
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Real-world progression free survival | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 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 |
| 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 | 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 |
Countries
Austria, Belgium, Germany, Spain, Sweden, Switzerland, United Kingdom
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed