BREAKOUT
Research type
Research Study
Full title
BREAKOUT -International Breast Cancer Biomarker, Standard of Care and Real World Outcomes Study
IRAS ID
222705
Contact name
Kwok-Leung Cheung
Contact email
Sponsor organisation
AstraZeneca UK LIMITED, Global Medicines Development, Medical Evidence and Observation Research
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 3 months, 22 days
Research summary
BREAKOUT is a biomarker research study to help understand how common certain types of genetic mutations in cancer related genes are in patients with breast cancer that has spread (metastatic). The genes analyzed are called breast cancer susceptibility genes (BRCA1 and BRCA2), and mutations on those genes may make some patients more likely to have breast cancer.
Participants must been diagnosed with a type of breast cancer known as metastatic human epidermal growth factor receptor 2 negative (HER2-negative breast cancer) and must have recently began chemotherapy (within the last three months).
The study will estimate how common the BRCA gene mutations are in the above population, and will also observe the treatments administered per standard of care and the associated clinical outcomes.
The participant sites will be selected among those hospitals that are not involved in clinical trials testing low poly ADP ribose polymerase inhibitor treatment, as the study wants to understand the response to treatments other than this inhibitor.
This study will take place in the hospitals and special cancer clinics. The patients will be followed for up to 2 years.REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
17/EM/0089
Date of REC Opinion
6 Apr 2017
REC opinion
Further Information Favourable Opinion