National study examining the treatment and outcome of patients diagnosed with breast cancer recurrence within the same breast/chest wall/nearby lymph glands
| ISRCTN | ISRCTN11908093 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11908093 |
| IRAS number | 285389 |
| Secondary identifying numbers | CPMS 50013, ABSGrantMARECA2020, IRAS 285389 |
- Submission date
- 16/09/2021
- Registration date
- 25/11/2021
- Last edited
- 11/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English Summary
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-the-management-of-breast-cancer-that-has-come-back-in-the-same-breast-or-nearby#undefined (added 24/03/2022)
Background and study aims
Although the 5-year UK breast cancer survival rate is favourable at 86.6%, patients continue to develop breast cancer recurrence within the same breast after breast-conserving surgery, as well as in the remaining skin or chest wall after mastectomy. Patients also present with breast cancer recurrence in the nearby lymph glands (under the arms or above/below the collarbone). These recurrences are collectively termed locoregional recurrence (LRR). It is estimated that up to 8% of breast cancer patients are diagnosed with LRR 10 years after their diagnosis.
Currently there is a lack of high-quality data and clinical guidance for the optimal management of breast cancer patients diagnosed with LRR. In the UK, breast cancer recurrence is under-reported at the individual hospital level to the national cancer registries. As a result, analysis of existing routine data sources is unlikely to provide data on patient management that is reflective of current national practice.
The aim of this study is determine the frequency, current management and prognosis of patients diagnosed with breast cancer LRR with or without distant metastasis in the UK with the aim of establishing best practice and informing future national guidelines. Over 50 UK breast units will participate in the study.
Who can participate?
Patients aged over 18 years treated for previous breast cancer
What does the study involve?
The researchers will establish a national prospective cohort of patients newly diagnosed with LRR (with or without distant metastasis) and describe how these patients are managed, and examine any geographical variation in the care received. The participants will be followed up at two timepoints (3 and 5 years) in order to determine patient survival outcome (breast cancer related or not), as well as the development of any further locoregional re-recurrence or distant metastasis. Patient survival analysis will identify prognostic factors, which will in turn generate hypotheses for future related studies with an aim of improving patient outcomes.
What are the possible benefits and risks of participating?
The researchers cannot promise that the study will benefit the study participant directly, but the information provided will help to improve the future management of patients diagnosed with breast cancer locoregional recurrence. There are no specific risks related to study participation. Taking part in this study will not change any treatment plans or investigations recommended by the medical team.
Where is the study run from?
Leeds Teaching Hospitals NHS Trust (UK)
When is the study starting and how long is it expected to run for?
September 2020 to January 2029
Who is funding the study?
Association of Breast Surgery (UK)
Who is the main contact?
Mr Baek Kim
leedsth-tr.themarecastudy@nhs.net
Contact information
Scientific
Department of Breast and Endocrine Surgery
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
 ORCID ID |
0000-0001-9759-7533 |
|---|---|
| Phone | +44 (0)113 20 68628 |
| leedsth-tr.themarecastudy@nhs.net |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | 40437_PIS_29Aug21_V3.0.pdf |
| Scientific title | The MARECA study - National study of management of breast cancer locoregional recurrence and oncological outcome |
| Study acronym | MARECA |
| Study hypothesis | For patients diagnosed with breast cancer locoregional recurrence (LRR), there is clinical uncertainty with regards to what constitutes optimal patient management and if geographical variations exist in patient care. The key areas that require evaluation include radiological staging investigations and the proportion of patients found to have distant metastasis at presentation, surgical management including the use of repeat breast-conserving surgery and sentinel lymph node biopsy, and information about adjuvant treatment modalities used, as well as the patient's subsequent prognosis. Collection of these data will provide a national picture of patient management and enable the identification of clinicopathological factors that predict patient prognosis. |
| Ethics approval(s) | Approved 07/09/2021, London - Brighton & Sussex Research Ethics Committee (Health Research Authority, 2 Redman Place, E20 1JQ, UK; +44 (0) 207104 8202; brightonandsussex.rec@hra.nhs.uk), REC ref: 21/PR/1128 |
| Condition | Breast cancer |
| Intervention | This is a prospective, observational, multicentre, longitudinal cohort study. This will be a national collaborative research study delivered in collaboration with the Association of Breast Surgery (ABS) Academic and Research committee and the breast surgery and oncology trainee associations (the Mammary Fold and UK Breast Cancer Trainees Research Collaborative Group). The study will have two main phases: National prospective cohort study: In 2021, over 50 UK breast units will aim to recruit consecutive eligible patients newly diagnosed with locoregional recurrence (LRR) +/- distant metastasis. The study will recruit patients for 24 months. Eligible patients will be identified at the breast MDT meetings or in breast and oncology clinics. We anticipate each unit to recruit 5 to 10 patients per year. Therefore, the anticipated sample size is 500 patients. All prospective consecutive patients will be approached and those that fulfil all the eligibility criteria will be given the Patient Information Sheet and given time to read the information and ask any questions about the study. Once the patient has had time to consider the information and ask questions, and if they choose to participate in the study, written informed consent will be obtained. Consent can be taken by the consultant breast surgeon or oncologist, breast surgery or oncology trainees, research nurses, or appropriately trained clinical trials assistants where delegated by the Chief/Principal Investigator. The patient consent will include the permission to collect pseudonymised data on the patient's initial and recurrent cancer treatment. This will include permission to examine the patient's survival and re-recurrence at 3 and 5 years after their LRR diagnosis. Patients will also be provided with the option of consenting for permission to access archival tumour tissue or slides of the initial and recurrent breast cancer for potential future related tissue substudy. Patients can participate in the main study without consenting to tissue or slide access. The participating patients will receive standard care and study participation will not result in additional tests, interventions, or clinic visits. Once patient consent has been obtained, consultant breast surgeon or oncologist, breast surgery or oncology trainees, research nurses, or clinical trials assistant will collect data detailing the tumour pathology, imaging results, surgical treatment, radiotherapy, and systemic therapy of initial and recurrent cancer for the study participant. These data are routinely collected as part of standard clinical practice. The study data will be recorded in a pseudonymised format using a secure web-based database (REDCap; hosted at the University of Manchester). This will enable the description of the current national practice including: 1. Modality of radiological staging investigations used and determination of the rate of detection of distant metastasis 2. Proportion of patients undergoing repeat breast-conserving surgery (BCS) 3. Proportion of patients undergoing repeat sentinel lymph node biopsy (SLNB), techniques used, and their success rate in terms of SLN identification 4. Adjuvant treatment modalities used to treat LRR 5. Proportion of patients undergoing breast surgery for LRR in the presence of distant metastasis Separately, a local secure record will be kept of the RedCap ID with corresponding NHS number (in England and Wales), Community Health Index number (in Scotland), or Health and Care number (in Northern Ireland) for future identification of patients. This is required for the research team at each participating centres to access the hospital electronic system to determine the follow up oncological outcome data for the study participants. Oncological outcome evaluation: At 3 and 5 year follow up after the LRR diagnosis, the research team at each participating unit (Consultant PI, research nurse, and clinical trial assistants) will also access the hospital electronic system to record survival and re-recurrence outcome for each study participants. Statistical survival analysis will be performed to determine patient survival and re-recurrence rates for the study cohort. There are planned statistical analyses to determine potential predictive factors that influence patient survival. A power calculation has determined that a subset of 330 patients diagnosed with LRR (without associated distant metastasis at presentation) are required to determine the study’s primary endpoint (disease-free survival following LRR resection, stratified according to the type of surgery performed for the initial breast cancer; BCS and radiotherapy vs mastectomy). The researchers will not anticipate direct patient contact for the study purpose during this follow up period as all the required information should be available on the hospital electronic system. In cases where the required information is missing or unclear, the research team may contact the patient or their General Practitioner via telephone. |
| Intervention type | Other |
| Primary outcome measure | Disease-free survival following locoregional recurrence resection measured using patient records at 3 and 5 years follow up |
| Secondary outcome measures | 1. Progression-free survival in patients who present with breast cancer locoregional recurrence with distant metastasis (3 and 5 years follow up). 2. Overall survival in patients diagnosed with breast cancer locoregional recurrence +/- distant metastasis at presentation (3 and 5 years follow up) |
| Overall study start date | 01/09/2020 |
| Overall study end date | 30/01/2029 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 700; UK Sample Size: 700 |
| Participant inclusion criteria | 1. Female or male patients more than 18 years old 2. Treated for previous unilateral or bilateral breast cancer (invasive cancer including all histological subtypes as well as ductal carcinoma in situ) with curative intent 3. No previous evidence of distant metastatic disease 4. Recently (within the last 6 months) diagnosed with new ipsilateral locoregional recurrence (biopsy-proven invasive cancer including all histological subtypes or ductal carcinoma in situ) +/- distant metastasis 5. Able to provide written informed consent 6. A minimum of 3 months interval between the resection surgery for the original cancer and the diagnosis of locoregional recurrence. There will be no maximum interval time period |
| Participant exclusion criteria | 1. Patients where the new breast cancer diagnosis is in the contralateral breast 2. For patients who present with new bilateral breast cancer, the side with no previous cancer will be excluded 3. Patients diagnosed with distant metastatic disease with no evidence of locoregional recurrence 4. Patients diagnosed with angiosarcoma 5. Patients with previous history of non-breast cancer treatment that was non-curative in intent 6. Patients who have had previous ipsilateral surgery for atypia, benign conditions, or phyllodes tumour and other breast sarcomas 7. Patients under 18 years old 8. Patients lacking the capacity to provide written informed consent |
| Recruitment start date | 08/11/2021 |
| Recruitment end date | 31/12/2023 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
Leeds
LS9 7TF
United Kingdom
London
SW3 6JJ
United Kingdom
Southampton
SO16 6YD
United Kingdom
Manchester
M13 9WL
United Kingdom
Westbury-On-Trym
Bristol
BS10 5NB
United Kingdom
Doncaster
DN2 5LT
United Kingdom
London
NW1 2PG
United Kingdom
Saintfield Road
Belfast
BT8 8BH
United Kingdom
Bradford
BD9 6RJ
United Kingdom
Poole
BH15 2JB
United Kingdom
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Harrogate
HG2 7SX
United Kingdom
Hull
HU3 2JZ
United Kingdom
Bangor
LL57 2PW
United Kingdom
Stirling
FK8 1DX
United Kingdom
Hamilton
ML3 0TA
United Kingdom
Cupar
KY15 5UP
United Kingdom
Exeter
EX2 5DW
United Kingdom
Wakefield
WF1 4DG
United Kingdom
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
Liverpool
L7 8XP
United Kingdom
Lindley
Huddersfield
HD3 3EA
United Kingdom
Calow
Chesterfield
S44 5BL
United Kingdom
2 Eday Road
Aberdeen
AB15 6RE
United Kingdom
Westcliff-On-Sea
SS0 0RY
United Kingdom
Crumpsall
Manchester
M8 5RB
United Kingdom
729 The Ridge
St. Leonards-On-Sea
TN37 7PT
United Kingdom
Londonderry
BT47 6SB
United Kingdom
Nottingham
NG7 2UH
United Kingdom
Lincoln
LN2 5QY
United Kingdom
Steeton
Keighley
BD20 6TD
United Kingdom
Maidstone
ME16 9QQ
United Kingdom
Hartlepool
TS24 9AH
United Kingdom
Farnworth
Bolton
BL4 0JR
United Kingdom
Guildford
GU2 7XX
United Kingdom
Truro
TR1 3LJ
United Kingdom
Edgbaston
Birmingham
B15 2GW
United Kingdom
Basingstoke
RG24 9NA
United Kingdom
Leicester
LE1 5WW
United Kingdom
London
SE5 9RS
United Kingdom
TA1 5DA
United Kingdom
Chester
CH2 1UL
United Kingdom
Colney
Norwich
NR4 7UY
United Kingdom
Dundee
DD3 8EA
United Kingdom
Portadown
BT63 5QQ
United Kingdom
Poole
BH15 2JB
United Kingdom
Hafan Derwen
St Davids Park
Jobswell Road
Carmarthen
SA31 3BB
United Kingdom
Sponsor information
Hospital/treatment centre
St. James's University Hospital
Beckett Street
Leeds
LS9 7TF
England
United Kingdom
| Phone | +44 (0)1132060469 |
|---|---|
| Anne.Gowing@nhs.net | |
| Website | http://www.leedsth.nhs.uk/home/ |
"ROR" |
https://ror.org/00v4dac24 |
Funders
Funder type
Other
Government organisation / Associations and societies (private and public)
- Alternative name(s)
- British Association of Surgical Oncology, ABS, BASO
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/01/2030 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | The researchers plan to publish the study protocol in the near future and intend to publish the results in a high-impact peer-reviewed journal. They anticipate the initial study results to be available in 2024. This will describe how patients with breast cancer locoregional recurrences are being managed across the UK. Subsequent publications will describe the long-term treatment outcome of the participating patients. |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 3.0 | 29/08/2021 | 23/09/2021 | No | Yes |
| Protocol file | version 3.0 | 29/08/2021 | 23/09/2021 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | National practice questionnaire of United Kingdom multi-disciplinary decision making | 01/07/2022 | 17/11/2023 | Yes | No |
| Participant information sheet | version 3.1 | 26/10/2022 | 11/12/2023 | No | Yes |
| Protocol file | version 4.0 | 25/05/2022 | 11/12/2023 | No | No |
Additional files
Editorial Notes
11/12/2023: The following changes were made to the trial record:
1. Uploaded protocol v4.0 (not peer-reviewed) as an additional file.
2. The participant information sheet v3.1 was uploaded as an additional file.
3. The target number of participants was changed from "Planned Sample Size: 700; UK Sample Size: 450" to "Planned Sample Size: 700; UK Sample Size: 700".
4. The study participating centres Addenbrooke's Hospital, Gartnavel Royal Hospital, New Cross Hospital, North Staffordshire Combined Healthcare NHS Trust, Royal Derby Hospital, Royal United Hospital, John Radcliffe Hospital, NHS Lothian, Cheltenham General Hospital, Northern General Hospital, York Hospital, Queen Elizabeth Hospital, The Royal London Hospital, Watford General Hospital, St Mary's Hospital.
17/11/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 08/11/2023 to 31/12/2023.
2. The target number of participants was changed from 500 to 700.
3. Publication reference added.
14/09/2022: Internal review.
24/03/2022: The Cancer Research UK plain English summary has been added.
16/09/2021: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).
