MAMMO-50: mammographic surveillance in breast cancer patients aged 50 years and over

ISRCTN	ISRCTN48534559
DOI	https://doi.org/10.1186/ISRCTN48534559
Secondary identifying numbers	16250

Submission date: 26/02/2014
Registration date: 26/02/2014
Last edited: 03/02/2025

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

http://www.cancerresearchuk.org/about-cancer/trials/This-trial-looking-follow-up-mammograms-women-over-50-who-have-had-breast-cancer

Study website

Contact information

Ms Amy Campbell
Scientific

Warwick Medical School Clinical Trials Unit
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom

Email	mammo-50@warwick.ac.uk

Prof Janet Dunn
Scientific

Warwick Clinical Trials Unit
Warwick Medical School
University of Warwick
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom

ORCID ID	0000-0001-7313-4446
Phone	+44 (0)24 7657 5847
Email	j.a.dunn@warwick.ac.uk

Study information

Study design	Randomised; Interventional and Observational; Design type: Treatment, Cohort study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	MAMMO-50: mammographic surveillance in breast cancer patients aged 50 years and over: a randomised controlled trial
Study acronym	MAMMO-50
Study hypothesis	The Government`s Cancer Reform Strategy recommends breast cancer patients be supported in self-care and have personalised risk-adjusted follow-up to meet their needs. As young age is a strong predictor of invasive and non-invasive 'second' breast cancer (i.e., recurrence on treated side or new cancer in opposite breast), current NICE 2009 guidance recommends patients diagnosed up to 50 years have mammograms annually. For those patients aged 50 or older at diagnosis, there is no clear evidence or consensus amongst specialists on risk factors to advise the optimum frequency or duration of follow-up mammograms. Type of breast surgery (mastectomy or conservation) does not affect long-term survival. However, 3 years after diagnosis, second breast cancers are found less frequently by mammography in mastectomy patients than those patients who have had conservation surgery. Early detection of second cancers or metastasis is more likely to occur via patient self-examination between mammograms than by specialist clinic visit. A patients ability to self-check and report concerns could be improved by alternative follow-up regimens including questionnaires and/or contact with nurses GPs, radiographers or internet access. There have been no randomised controlled trials in this setting. In order to provide sound evidence for future management, this clinical trial aims to establish if patients aged 50 years or over can be identified who require less frequent mammographic surveillance whilst investigating alternative methods of follow-up.
Ethics approval(s)	First MREC approval date 11/12/2013, ref: 13/WM/0419
Condition	Topic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast
Intervention	For the purposes of MAMMO-50, centres will utilise digital imaging in line with the national roll-out of digital screening mammography in 2010. Digital mammography offers advantages in terms of image quality, increased sensitivity in important subgroups (e.g., women with dense breasts) and reduced examination time that permits a greater opportunity for patient contact with the radiographer or breast care nurse. It is also reported to deliver significantly less radiation than conventional mammography. In addition to the mammogram, eligible patients will be asked to complete the MAMMO-50 patient questionnaire booklet, delivered at the time of their mammogram or clinical follow-up, which will include questions on their general health, health resource use and adherence to prescribed maintenance therapy such as Tamoxifen or Arimidex. In addition the patient and public Involvement (PPI) component of the study will evaluate adequacy of current information offered as standard to patients as well as effective ways of collecting quality of life data for those patients consenting to be part of the QoL and/or qualitative sub-studies.
Intervention type	Other
Primary outcome measure	1. Disease-specific survival 2. Cost effectiveness The first Mammo-50 patient questionnaire booklet, which will include general questions, Health Resource Use forms and EQ-5D-5L, must be given to patients after written consent is obtained but prior to randomisation. Further Mammo-50 patient questionnaire booklets will be administered around the time of scheduled mammograms, i.e. annually from randomisation for more frequent mammogram schedule and 2 or 3 years for the less frequent mammogram schedule, up to 10 years post curative surgery.
Secondary outcome measures	1. Recurrence (time to recurrence, type of recurrence and features of recurrence plus new primary in ipsilateral breast and new primary in contralateral breast) using questionnaire and data linkage. The NCIN lead registry for breast cancer will match the MAMMO-50 cohort against the national cancer registration database at 3-yearly intervals for 3 years (3, 6 and 9 years after randomisation). Details of recurrent breast cancers (local, regional and distant) will be provided as will dates and causes of death where appropriate. The histological characteristics of ipsilateral breast tumour recurrences (IBTR) and contralateral new primaries will be recorded and the Nottingham Prognostic Index (NPI) calculated and compared to the NPI of the original tumour. These characteristics will include invasive and in situ tumour size, histological grade, histological type, vascular invasion status, ER, PR and HER-2 status, in those tumours treated by immediate surgical resection. Nodal status will be recorded in those who have a further nodal procedure. In tumours treated with systemic therapy and no surgery (this is common if metastatic disease is found at the time of recurrence) tumour type and grade and receptor status will be ascertained from the diagnostic core biopsy and lesion size estimated from imaging 2. Number of referrals back to the hospital system 3. Long-term survival (20 years post-surgery) using ONS flagging
Overall study start date	01/09/2013
Overall study end date	30/09/2025

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Planned Sample Size: 7000; UK Sample Size: 7000; Description: Main trial: 5000 patients; Observational cohort: 1000 patients
Total final enrolment	6150
Participant inclusion criteria	1. Female, age >= 50 at initial cancer diagnosis 2. Excised invasive breast cancer with local treatment completed 3. Three years post curative surgery date 4. Written informed consent for the study
Participant exclusion criteria	1. Breast cancer recurrence, new breast cancer primary or any new malignancies 2. Previous diagnosis of malignancy unless managed by surgical treatment only and disease free for 10 years or previous basal cell carcinoma of skin, cervical intraepithelial neoplasia or in situ ductal carcinoma of the breast treated with surgery only
Recruitment start date	01/09/2013
Recruitment end date	30/09/2018

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

Warwick Medical School Clinical Trials Unit

Coventry
CV4 7AL
United Kingdom

115 participating centres

-
United Kingdom

Sponsor information

University of Warwick (UK)
University/education

Warwick Medical School
Coventry
CV4 7AL
England
United Kingdom

"ROR"	https://ror.org/01a77tt86

Funders

Funder type

Government

Health Technology Assessment Programme
Government organisation / National government

Alternative name(s): NIHR Health Technology Assessment Programme, HTA
Location: United Kingdom

Results and Publications

Intention to publish date	31/03/2026
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal. Added 12/05/2021: Protocol at https://www.journalslibrary.nihr.ac.uk/programmes/hta/112503/#/ Added 23/05/2023: Intended dates of publication for primary analysis is 31/03/2024 and for long-term follow-up analysis is 31/03/2026.
IPD sharing plan	Data collected within the Mammo-50 trial will be made available to researchers whose full proposal for their use of the data has been approved by the Mammo-50 Trial Management Group and whose research group includes a qualified statistician. Any requests for access to the trial data should be sent to the Chief Investigator, Professor Janet Dunn, who will inform the data custodian, the University of Warwick. Please send requests via email to mammo-50@warwick.ac.uk. Each data sharing request should include the purpose, scope, data items requested, analysis plan, acknowledgement of the trial management team and evidence of appropriate ethical approvals. Requestors who are granted access to the data will be required to complete a data-sharing agreement, which will be signed by the requester, sponsor and principal investigator(s). We anticipate that data sharing will be possible after the publication of the primary endpoint of the trial and will remain available up to 5 years from the end of the trial.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol file	version 4.0	07/07/2021	23/05/2023	No	No
HRA research summary			28/06/2023	No	No
Results article		01/02/2025	03/02/2025	Yes	No

Additional files

ISRCTN48534559 Protocol v4.0 07Jul2021.pdf

Editorial Notes

03/02/2025: Publication reference added.
23/05/2023: The following changes were made to the trial record:
1. The overall end date was changed from 30/03/2026 to 30/09/2025.
2. The intention to publish date was changed from 30/09/2026 to 31/03/2026.
3. The publication and dissemination plan was updated.
4. Uploaded protocol (not peer-reviewed) as an additional file.
12/05/2021: Total final enrolment number and IPD sharing statement added, publication and dissemination plan and contact details updated.
09/11/2018: Publication and dissemination plan, IPD sharing statement, and contact details added.
07/08/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2018 to 30/09/2018.
2. The overall trial end date was changed from 30/06/2018 to 30/03/2026.
3. The intention to publish date was added.
4. The target number of participants for the observational study was changed from up to 2000 patients to 1000 patients.