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

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Medical Conditions
  • Topic: National Cancer Research Network
  • Subtopic: Breast Cancer
  • Disease: Breast
Primary Contact Details
Recruitment Status
Recruiting
Trial source and source ID number
ISRCTN48534559
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
http://www.cancerresearchuk.org/about-cancer/trials/This-trial-looking-follow-up-mammograms-women-over-50-who-have-had-breast-cancer
Research Details
  • 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 patientÂ’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
Phase
Not Applicable
Study Design
Randomised; Interventional and Observational; Design type: Treatment, Cohort study
Study Type
Interventional
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 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
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Female
Age Range
Adult
Who Can Participate
Patient
Number of Participants
Planned Sample Size: 7000; UK Sample Size: 7000; Description: Main trial: 5000 patients; Observational cohort: up to 2000 patients
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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Coventry
CV4 7AL
Trial Contact(s)
Primary Trial Contact
Ms Maria Ramirez
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
MAMMO-50: mammographic surveillance in breast cancer patients aged 50 years and over: a randomised controlled trial
EudraCT Number
Sorry, this information is not available
Funder(s)
  • NIHR Health Technology Assessment Programme - HTA (UK)
Other Study ID Numbers
16250
Sponsor(s)
University of Warwick (UK)
Key Dates

Recruitment Start Date

01 Sep 2013

Recruitment End Date

30 Jun 2018

Trial Start Date

01 Sep 2013

Trial End Date

30 Jun 2018

Date added to source

26 Feb 2014

Date updated in source

03 Oct 2014