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.

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