ML29659 - ESTHER - Disease Registry Study
Research type
Research Study
Full title
UK - A disease Registry Study to Prospectively Observe treatment Patterns and Outcomes in Patients with HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
IRAS ID
165983
Contact name
Alistair Ring
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Duration of Study in the UK
8 years, 0 months, 0 days
Research summary
Summary of research
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 Locally Advanced/Metastatic Breast Cancer, where surgery is not being planned for curative intent.Summary of Results
A lay patient summary is not required for non-interventional studies (NIS).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.
The study will look at how patients cope with these anti-cancer treatments and how their breast cancer responds to them. The study will not change how patients are treated and assessed by their doctors.
This is an observational study therefore patients will not undergo any extra tests or procedures for the purpose of the study. Data will be collected from tests/procedures performed as part of the patients standard of care.
The study will recruit 390 patients from 28 hospitals, over a 3 year recruitment period. Once recruitment is complete patients will be followed up for a minimum period of 5 years.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
14/EM/1307
Date of REC Opinion
22 Dec 2014
REC opinion
Favourable Opinion