Real-world Treatment Patterns and Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor as Initial Endocrine Based Therapy in Metastatic/Advanced Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Palbociclib + an aromatase inhibitor
- Conditions
- Metastatic Breast Cancer
- Sponsor
- Pfizer
- Enrollment
- 813
- Locations
- 1
- Primary Endpoint
- Real-World Progression Free Survival (rwPFS): Using Kaplan-Meier Method
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
A retrospective observational analysis of de-identified Flatiron Health Analytic Database to describe patient characteristics, treatment patterns and effectiveness of Palbociclib + AI as first-line therapy in HR+/HER2- metastatic breast cancer (MBC) in the US clinical practices.
Detailed Description
Utilizing de-identified data derived from the Flatiron Health Analytic Database, the retrospective observational study is to describe patient characteristics, treatment patterns and effectiveness of Palbociclib + AI as first-line therapy in HR+/HER2-MBC in the US real-world clinical practice setting. Patients will be evaluated retrospectively from index therapy date to death, or last visit in the database, whichever comes first. Descriptive and multivariate statistical analyses will be performed.
Investigators
Eligibility Criteria
Inclusion Criteria
- •At least 18 years old at MBC diagnosis
- •Diagnosis of MBC at any point in patient history
- •ICD-9 (174.x, 175.x) or ICD-10 (C50.xx) diagnosis of BC
- •Confirmation of metastatic disease
- •At least 2 document clinical visits
- •Evidence of stage IV or recurrent MBC with a metastatic diagnosis date on or after 2011, as confirmed by unstructured clinical documents
- •HR+: ER+ or PR+ test before or up to 60 days after MBC diagnosis
- •HER2-: any HER2 negative test and the absence of a positive test (IHC positive 3+, FISH positive/amplified, Positive NOS) before or up to 60 days after MBC diagnosis
- •Palbociclib + AI or letrozole as first-line therapy for MBC during the period from February/2015 through August /31/2018 (or 3 months prior to study cut-off date) to allow for a possible minimum follow-up time of 90 days until the study cutoff date. AI was administered within (±) 28 days of Palbociclib index date.
Exclusion Criteria
- •Evidence of prior treatment with other CDK4/6I (Ribociclib or Abemaciclib), AI (Letrozole, Exemestane, and Anastrazole), Tamoxifen, Raloxifene, Toremifene, or Fulvestrant for MBC
- •First structured activity greater than 90 days after MBC diagnostic date
- •Treatment with a CDK4/6 inhibitor as part of a clinical trial
Arms & Interventions
Palbociclib + an aromatase inhibitor
Adult metastatic breast cancer patients who initiated Palbociclib + an aromatase inhibitor as first line therapy between Feb 3, 2015 to 3 months prior to date of data cutoff in the Flatiron Health Analytic Database.
Intervention: Palbociclib + an aromatase inhibitor
Palbociclib + Letrozole
Adult metastatic breast cancer patients who initiated Palbociclib +Letrozole as first line therapy between Feb 3, 2015 to 3 months prior to date of data cutoff in the Flatiron Health Analytic Database.
Intervention: Palbociclib + Letrozole
Letrozole
Adult metastatic breast cancer patients who initiated Letrozole as first line therapy between Feb 3, 2015 to 3 months prior to date of data cutoff in the Flatiron Health Analytic Database.
Intervention: Letrozole
Outcomes
Primary Outcomes
Real-World Progression Free Survival (rwPFS): Using Kaplan-Meier Method
Time Frame: From index date to death or disease progression or end of record/data availability or censored date, whichever occurred first, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study)
rwPFS was defined as time (in months) from index date to death or disease progression (growth or worsening in the disease concluded by the treating clinician based on radiology, laboratory evidence, pathology, or clinical assessment) or end of record or end of data availability, whichever occurred first. If participants did not die or had disease progression, they were censored at the date of initiation of next line of therapy for participants with two or more lines of therapy or their last visit date for participants with only one line of therapy. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis.
Secondary Outcomes
- Overall Survival (OS): Using Kaplan-Meier Method(From index date to death, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study))
- Real-World Duration of Treatment (rwDOT): Using Kaplan-Meier Method(From index treatment initiation up to end of treatment, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study))
- Time to First Use of Chemotherapy: Using Kaplan-Meier Method(From index treatment initiation to first use of chemotherapy or death from any cause, whichever occurred first, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study))
- Response Rate(From index date to CR or PR, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study))
- Number of Participants With Real World Tumour Response (rwTR)(From index date to CR/PR/PD/SD pr PD, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study))
- Time From Index Date to Next Line of Anti-Cancer Therapy: Using Kaplan-Meier Method(From index treatment initiation up to next line of anti-cancer therapy or death from any cause, whichever occurred first, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study))