Condition category
Cancer
Date applied
26/02/2014
Date assigned
26/02/2014
Last edited
03/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Ms Maria Ramirez

ORCID ID

Contact details

Warwick Medical School Clinical Trials Unit
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom
mammo-50@warwick.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16250

Study information

Scientific title

MAMMO-50: mammographic surveillance in breast cancer patients aged 50 years and over: a randomised controlled trial

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 patient’s 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.

More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=16250

Ethics approval

First MREC approval date 11/12/2013, ref. 13/WM/0419

Study design

Randomised; Interventional and Observational; Design type: Treatment, Cohort study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/09/2013

Overall trial end date

30/06/2018

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 7000; UK Sample Size: 7000; Description: Main trial: 5000 patients; Observational cohort: up to 2000 patients

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

30/06/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

University of Warwick (UK)

Sponsor details

Warwick Medical School
Coventry
CV4 7AL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes