The MARECA Study

The MARECA Study- National Study of Management of Breast Cancer Locoregional Recurrence and Oncological Outcome

Background

Despite continuing improvements in breast cancer treatment and patient prognosis, patients continue to develop locoregional recurrence (LRR). The 10-year cumulative incidence of LRR is reportedly as high as 8%.
 
Patients either present with in-breast local recurrence after breast conserving surgery (BCS) and radiotherapy or with chest wall local recurrence after mastectomy. The Early Breast Cancer Trialists’ Collaborative Group meta-analyses suggest that patients in the former group may have better subsequent prognosis. Breast cancer can also recur in the ipsilateral regional lymph nodes (axilla, supra- or infra-clavicular, or internal mammary chains). 
 
Currently there is a lack of high-quality data and clinical guidance for the optimal management of breast cancer patients diagnosed with LRR. Additionally, there is a need to identify prognostic factors, which will enable treatment tailoring to improve future patient outcomes.
 
Study description

The MARECA study will be a prospective, multicentre, longitudinal cohort study delivered in collaboration with the breast surgery and oncology trainee associations (The Mammary Fold and Breast Cancer Trainees Research Collaborative Group). The study will commence in 2021 and aims to recruit consecutive eligible patients diagnosed with LRR +/- distant metastasis at participating centres (24 months patient recruitment period). So far 49 UK Breast Units have agreed to participate in the study. We anticipate each unit to see 5-10 patients with LRR +/- distant metastasis each year. Therefore, the predicted minimum sample size is 490 patients.

Aims

The MARECA study will determine the frequency, current management and prognosis of patients diagnosed with breast cancer LRR in the UK with the aim of establishing best practice and informing future national guidelines.  
 
Objectives
 
To establish a prospective cohort of breast cancer patients diagnosed with LRR in order to
i)               Describe current management including:
·       Use of radiological staging investigations and the proportion of patients found to have distant metastasis at presentation.
·       Surgical management including the use of repeat BCS and sentinel lymph node biopsy. 
·       Use of systemic therapies and radiotherapy used to treat LRR.
ii)              Investigate risk factors associated with LRR development including those related to the primary breast cancer and its management.
iii)             Determine oncological outcome including disease free survival (DFS), progression free survival (PFS), and overall survival (OS) at 3 and 5 years, and evaluate prognostic factors. 
iv)            Stratify LRR as a true recurrence or a new primary breast cancer using clinical classification systems and explore if this distinction affects oncological outcomes.
v)              To evaluate the completeness of LRR reporting to the national cancer registry and the validity of using routine data sources in future studies. 
 
Study endpoints

Primary endpoint:
-DFS following LRR resection, stratified according to the type of surgery performed for the primary breast cancer (BCS and radiotherapy vs. mastectomy).

Secondary endpoint:
-PFS and OS in patients with LRR +/- distant metastasis at presentation. 
 
Steering group members

Baek Kim (lead investigator), Ramsey Cutress, Ellen Copson, Lynda Wyld, Cliona Kirwan, Stuart McIntosh, Shelley Potter, Kieran Horgan, Peter Barry, Rajiv Dave, Raj Achuthan, Brian Hogan, Neill Patani, Patricia Fairbrother (patient representative), Rachel O’Connell, Tim Rattay, Jenna Morgan, Vinton Cheng (BCTRCG Lead), Lisa Sheehan (MFAC lead), Gurdeep Mannu, Sue Hartup, Eldo Verghese, Mujiba Ejaz (NHS Digital representative)
 
Participating centres
 
The following 49 breast units have agreed to participate in the study so far

St. James’s University Hospital, Leeds, Brian Hogan
The Royal Marsden Hospital, London, Peter Barry
University Hospital Southampton NHS Foundation Trust, Ramsey Cutress
Manchester University NHS Foundation Trust, Rajiv Dave
Bristol Breast Care Centre, North Bristol NHS Trust, Shelley Potter
University Hospitals of Leicester NHS Trust, Monika Kaushik
The Jasmine Breast Centre, Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust, Lynda Wyld
University College London Hospitals NHS Foundation Trust, Neill Patani
Oxford University Hospitals Foundation Trust, Dennis Remoundos
Belfast City Hospital, Stuart McIntosh
Bradford Royal Infirmary, Rick Linforth
Poole Hospital NHS Foundation Trust, Sarah Clark
Royal Victoria Infirmary, Newcastle, Henry Cain
Harrogate and District NHS Foundation Trust, Biswajit Ray
Castle Hill Hospital, Cottingham, Peter Kneeshaw
Glan Clwyd Hospital, Wales, Mandana Pennick
Addenbrooke’s Hospital, Cambridge, John Benson
NHS Lanarkshire, Fife, and Forth Valley, Scotland, Chris Cartlidge
Royal Devon and Exeter NHS Foundation Trust, Charlotte Ives
The Mid Yorkshire Hospitals NHS Trust, Dan Glassman
Milton Keynes University Hospital, Gaural Patel
Royal Liverpool NHS Foundation Trust, Matthew Rowland
NHS Greater Glasgow and Clyde, Laszlo Romics
Calderdale and Huddersfield NHS Foundation Trust, Richard Frame
Chesterfield Royal Hospital NHS Foundation Trust, Julia Massey
Aberdeen Royal Infirmary, Beatrix Elsberger
Southend University Hospital NHS Foundation Trust, Harun Thomas
The Royal Wolverhampton NHS Trust, Raghavan Vidya
The Pennine Acute Hospitals NHS Trust, Kate Williams
East Sussex Healthcare NHS Trust, Ash Subramanian
Western Health and Social Care Trust, Northern Ireland, Brendan Skelly
University Hospital North Staffordshire, Stoke on Trent, Soni Soumian
University Hospital of Derby and Burton NHS Foundation Trust, Amit Goyal
Nottingham University Hospitals NHS Trust, Ellie Gutteridge
United Lincolnshire Hospitals NHS Trust, Dinesh Thekkinkattil
Royal United Hospitals Bath NHS Foundation Trust, Richard Sutton
Airedale NHS Foundation Trust, Elizabeth Baker
Maidstone and Tunbridge Wells NHS Trust, Karina Cox
North Tees and Hartlepool NHS Foundation Trust, Matei Dordea
Edinburgh Breast Unit, NHS Lothian, Matthew Barber
Bolton NHS Foundation Trust, Sreekumar Sundara Rajan
Gloucestershire Hospitals NHS Foundation Trust, Fiona Court
Sheffield Teaching Hospitals NHS Foundation Trust, Loaie Maraqa
Royal Surrey County Hospital NHS Foundation Trust, Liz Clayton
Royal Cornwall Hospitals NHS Trust, Polly King
York Teaching Hospital NHS Foundation Trust, Jenny Piper
Gateshead Health NHS Foundation Trust, Rob Milligan
University Hospitals Birmingham NHS Foundation Trust, Salena Bains
Hampshire Hospitals NHS Foundation Trust, Siobhan Laws
King’s College Hospital NHS Foundation Trust, Sudeendra Doddi
Barts Health NHS Trust, Serena Ledwidge
Somerset NHS Foundation Trust, Zoe Goldthorpe
Countess of Chester Hospital NHS Foundation Trust, Anita Hargreaves
Norfolk and Norwich University Hospitals NHS Foundation Trust, Mina Youssef
West Hertfordshire Hospitals NHS Trust, Lee Min Lai
NHS Tayside, Alessio Vinci
 
Contact details
 
Please contact the MARECA study team (leedsth-tr.themarecastudy@nhs.net) to register your interest. We especially welcome participation from trainees.
 
Study update
 
The study protocol, patient information sheet, consent form, and CRF will be made available on the iBRA-NET website shortly. We have now launched the MARECA study National Practice Questionnaire. This consists of scenario-based questions for the MDT, which is designed to capture data on practice variation and areas of uncertainty. Please complete the questionnaire with your multidisciplinary team using this SurveyMonkey link
 

 
We will aim to collate and analyse this data in order to disseminate it for future academic outputs.