AN OBSERVATIONAL STUDY OF CARDIAC EVENTS IN PATIENTS WITH HER2- POSITIVE METASTATIC BREAST CANCER WHO HAVE A LEFT VENTRICULAR EJECTION FRACTION (LVEF) BETWEEN 40%-49% PRIOR TO INITIATING TREATMENT WITH KADCYLA®

Study identification

• EU PAS number:
  EUPAS20684
• Study ID:
  32784
• Official title and acronym:
  AN OBSERVATIONAL STUDY OF CARDIAC EVENTS IN PATIENTS WITH HER2- POSITIVE METASTATIC BREAST CANCER WHO HAVE A LEFT VENTRICULAR EJECTION FRACTION (LVEF) BETWEEN 40%-49% PRIOR TO INITIATING TREATMENT WITH KADCYLA®
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is an observational study of cardiac events in patients with HER2-positive metastatic breast cancer who have a left ventricular ejection fraction (LVEF) between 40-49% prior to initiating treatment with Kadcyla. This is a secondary data use following a single retrospective cohort design. Flatiron Health Analytic Database processes data from multiple electronic health records (EHRs), including oncology specific EHRs (e.g., OncoEMR) and general EHRs (e.g., Epic, Cerner). This processing includes both structured data (i.e., data points that are organized in a predefined manner, such as drop-down fields that reside in the EHR to capture a patient’s gender or date of birth) and unstructured data (i.e., information that is not organized in a pre-existing data model, such as free text from a physician’s note or lab report).
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Planned:31/01/2016

Actual:31/01/2016

Study start date

Planned:23/11/2017

Actual:21/11/2017

Data analysis start date

Planned:23/11/2017

Actual:21/11/2017

Date of interim report, if expected

Planned:31/05/2018

Date of final study report

Planned:31/05/2019

Actual:09/04/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

F. Hoffmann-La Roche Ltd.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

BO39807