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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/26411
• EU PAS number:
  EUPAS23334
• Study ID:
  26411
• Official title and acronym:
  UK – A DISEASE REGISTRY STUDY TO PROSPECTIVELY OBSERVE TREATMENT PATTERNS AND OUTCOMES IN PATIENTS WITH HER2-POSITIVE UNRESECTABLE LOCALLY ADVANCED OR METASTATIC BREAST CANCER (ESTHER)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This disease registry is a prospective, multicentre, non-interventional study designed to observe anti-cancer treatment regimens and clinical outcomes with these regimens in patients with human epidermal growth factor receptor 2 (HER2)-positive unresectable LA/mBC. Patients can be enrolled in the study irrespective of the anti-cancer treatment they are prescribed. Once a patient is enrolled in the study, she/he will be followed until death, withdrawal of consent or study termination, whichever occurs first.
• Study status:
  Finalised

Research institution and networks

Institutions

F. Hoffmann-La Roche

The study will be performed at approximately 28 sites.

Study timelines

Date when funding contract was signed

Planned: 13/11/2014

Actual: 13/11/2014

Study start date

Planned: 23/02/2015

Actual: 23/02/2015

Data analysis start date

Planned: 16/03/2023

Actual: 19/04/2023

Date of final study report

Planned: 31/12/2024

Actual: 15/02/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Roche Products Limited

Study protocol

Initial protocol

ML29659_PROTOCOL_Redacted

Updated protocol

ML29659 - Protocol v5_03-Mar-2022_Redacted.pdf

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

ML29659, ESTHER