An Observational Study of Cardiac Events in Patients With HER2 Positive Early Breast Cancer Treated With Herceptin® (OHERA)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/23949
• EU PAS number:
  EUPAS9914
• Study ID:
  23949
• Official title and acronym:
  An Observational Study of Cardiac Events in Patients With HER2 Positive Early Breast Cancer Treated With Herceptin® (OHERA)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Germany

  Hungary

  Italy

  Poland

  Spain

  Sweden

  United Kingdom
• Study description:
  This observational, single-arm cohort safety study has been designed to observe the occurrence of cardiac events in participants with HER2-positive early breast cancer treated with trastuzumab (Herceptin®) in daily clinical practice. All participants will be treated and monitored according to the local clinical practice. No additional procedures or visits in comparison with the usual clinical practice are planned for the study. Data will be collected from medical records for up to 5 years or until death, loss to follow-up, or withdrawal of informed consent.
• Study status:
  Finalised

Research institution and networks

Institutions

F. Hoffmann-La Roche

Multiple centres: 199 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 01/05/2006

Study start date

Actual: 31/08/2007

Data analysis start date

Actual: 30/09/2008

Date of final study report

Planned: 31/05/2017

Actual: 23/06/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Hoffmann-La Roche

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

BO20652