Topic: National Cancer Research Network
Conditions
Interventions
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
Sponsors
University of Warwick (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Outcome results
None listed