Treatment Patterns And Clinical Outcomes Among Patients Receiving CDK4/6 Inhibitors Combinations For HR+/HER2- Advanced/Metastatic Breast Cancer In A Canadian Real World Setting
Conditions: Breast Cancer
Sponsor: Pfizer



Palbociclib 
A5481178 NON-INTERVENTIONAL STUDY PROTOCOL 
Version 3.0, 13 February 2023 
 
 
PFIZER CONFIDENTIAL  
 
20-May-2021 
Page 17 of 24 
9.4. Data sources  
Patients will be selected with dates of diagnosis of HR+/HER2- ABC/MBC between 01 
January 2016 and 01 July 2021. Study data will be extracted from Sinai Health EHRs up to 12 
months before ABC/MBC diagnosis until the end of the study period (01 October  2021, Figure 
1). 
9.5. Study size 
All female patients who are ≥18 years of age and are diagnosed with HR+/HER2- ABC/MBC 
at Sinai Health during the study period will be included in the study. It is estimated that there 
will be approximately 300 diagnoses of ABC/MBC within the study period at Sinai Health, of 
which approximately 180 will be HR+/HER2-. All analyses are descriptive in nature and so 
sample size calculations are not applicable. 
9.6. Data management  
At Sinai Health’s direction, DARWEN™ shall run in a secure environment that meets Siniai 
Health’s IT and privacy requirements. DARWEN™ engine structures data optionally on a 
compute cluster, using models supported/reinforced, if needed, through additional training on 
Sinai Health data. DARWEN™ engine outputs patient-level data which can be structured as 
a Comma separated values (CSV) on the VM.  
Data extracted from Sinai Health EHRs and curated by DARWEN™ will be retained by Sinai 
Health for research purposes in a row and column dataset in the file-type/format of their 
choosing. Sinai Health retains all ownership and rights to the data. 
Pentavere will provide Pfizer with aggregate data following Sinai Health’s approval. 
Aggregate data will be sent to Pfizer directly from Sinai Health by Pentavere when directed to 
do so by Sinai Health, and, if requested, a secured share drive can be created for data storage 
and transfer. Pentavere will comply with Sinai Health procedures regarding content, archiving, 
records management of process documents, and electronic transfer of these aggregate data. 
 
9.6.1. Case report forms/Data collection tools/Electronic data record 
As described above, data extracted from Sinai Health EHRs and curated by DARWEN™ 
compliant process will result in de-identified aggregated patient data.   
 
9.6.2. Record retention 
To enable evaluations and/or inspections/audits from regulatory authorities or Pfizer, the third 
party responsible (Sinai Health/Pentavere) agrees to keep records, including the identity of all 
participating patients, safety reporting forms, source documents, detailed records of treatment 
disposition, and adequate documentation of relevant correspondence (e.g., letters, meeting 

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