A EUROPEAN DISEASE REGISTRY STUDY TO PROSPECTIVELY OBSERVE TREATMENT PATTERNS AND OUTCOMES IN PATIENTS WITH HER2-POSITIVE UNRESECTABLE LOCALLY ADVANCED OR METASTATIC BREAST CANCER (SAMANTHA)

Study identification

• EU PAS number:
  EUPAS22426
• Study ID:
  25822
• Official title and acronym:
  A EUROPEAN DISEASE REGISTRY STUDY TO PROSPECTIVELY OBSERVE TREATMENT PATTERNS AND OUTCOMES IN PATIENTS WITH HER2-POSITIVE UNRESECTABLE LOCALLY ADVANCED OR METASTATIC BREAST CANCER (SAMANTHA)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Bulgaria

  Italy

  Portugal

  Romania
• Study description:
  This observational disease registry is part of a global umbrella study, UMBTDM1, and is a prospective, multinational, multicentre non-interventional study designed to observe clinical outcomes, patient-reported outcomes, Quality of Life and health economics across anti-cancer treatment regimens and sequences during the course of HER2-positive unresectable locally advanced (LA)/metastatic breast cancer (mBC) in Europe.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Planned:20/05/2016

Actual:20/05/2016

Study start date

Planned:16/11/2016

Actual:16/11/2016

Date of final study report

Planned:18/12/2024

Actual:31/01/2024

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)?:
  Not applicable

Other study registration identification numbers and links

MO39146