SWAG SSG Breast Cancer Meeting Clinical Research Network West of England SWAG SSG Breast Cancer Meeting Friday 27th January 2017 Research Report

Clinical Research Network & Cancer Services West ofEngland SWAG - Somerset Wiltsire Avon & Gloucestershire South West Children’s Cancer & Leukaemia Research Network

NIHR CRN High Level Objectives Increase number of participants into NIHR CRN portfolio studies 650,000 in England 21,905 in West of England Increase the number of studies that deliver to time and target Target 80% Increase number of commercial studies delivered through network Reduce NHS study set up times Reduce time taken to recruit first participant

NIHR CRN Objectives for cancer Recruit 20% of cancer incidence West of England 1,909 Recruit 7.5% of cancer incidence into interventional studies 716 Include challenging studies Cancer surgery – 4 recruits per 100,000 population Radiotherapy – 6 recruits per 100,000 population Rare cancers (<6 per 100,000) – 12 recruits per 100,000 population Children & young people – 3 per 100,000 population Teenagers & young adults – record number of 16-25 year olds participating in research

*Please note the Office of National Statistics uses different regions from the NIHR so this calculation is approximate. The South West region loosely correlates to West of England and South West Peninsula CRNs, with the addition of Dorset.

West of England recruitment to Cancer studies per Trust

What does the current portfolio look like? 23 Studies 8 Acute Trusts in the SWAG region. 72% of study sites are currently meeting Recruitment to Time and Target (RTT) POSNOC in Bath M12-914 Phase III Veliparib/ Placebo + C/P Breast Cancer Study in University Hospitals Bristol Breast cancer studies open in SWAG largely reflect a balanced portfolio by sub-topic, though only 1 metastatic study is open at present

Current portfolio balance

Studies in set up – Breast Cancer Portfolio ID Study Title Project type Trust Principal Investigator 16444 CiPHER - Cabazitaxel in Patients with HER2-negative metastatic breast cancer and having unresectable brain metastases Non-commercial University Hospitals Bristol Bahl, Dr Amit 19708 IBIS 3: POLaR - Prevention Of Late Recurrence in ER+ breast cancer survivors following 5 years of adjuvant treatment   19754 Exercise to prevent shoulder problems (PROSPER) 30433 PARTNER - addition of olaparib to platinum-based neoadjuvant chemotherapy in breast cancer patients with TNBC and/or gBRCA Braybrooke, Dr Jeremy 31440 CompLEEment-1 - ribociclib (LEE011) in combination with letrozole for the treatment of men and postmenopausal women with hormone receptor-positive (HR+) HER2-negative (HER2-) advanced breast cancer Commercial 31608 plasmaMATCH - The UK plasma based Molecular profiling of Advanced breast cancer to inform Therapeutic Choices 32994 PALLAS - Palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for HR+ / HER2 - early breast cancer

Current issues with breast cancer research Clinical pressures with some trial treatments Pharmacy capacity issues Extra time for administration of infusions Extra length of treatment courses Clinic space to see patients Affordability to the NHS of the drugs we are researching What should our regional portfolio look like? Should we consider the whole region population when forecasting for trials? Should we encourage more cross referral of patients for studies? Should we select studies that will be more useful to the NHS?

Useful links https://www.crn.nihr.ac.uk/ National and local network information including training programmes templates, tools, contacts, videos etc https://odp.nihr.ac.uk/ http:/ Open data platform. Look at performance across whole CRN including all specialty areas /csg.ncri.org.uk/portfolio/portfolio-maps/ View current national portfolio of open, closed and ‘in set up’ cancer studies https://www.ukctg.nihr.ac.uk/ See where a study is open across the country http://public-odp.nihr.ac.uk/  Search for a study to fit criteria. Good for horizon scanning, eligibility criteria

Contacts Research Delivery Manager – maxine.taylor@nihr.ac.uk Cancer portfolio facilitator – sarah.west@nihr.ac.uk Breast cancer research lead – mark.beresford@nhs.net