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. 2026 May;30(38):1–15. doi: 10.3310/GJJD0722

Mammographic surveillance in breast cancer patients aged 50 years or older: a synopsis of the Mammo-50 RCT.

Janet Dunn, Peter Donnelly, Andrea Marshall, Nada Elbeltagi, Amy Hopkins, Maria Ramirez, Alastair Thompson, Riccardo Audisio, Sarah Pinder, David Cameron, Sue Hartup, Maggie Wilcox, Lesley Turner, Annie Young, Helen Higgins, Eila Watson, Sophie Gasson, Peter Barrett-Lee, Claire Hulme, Bethany Shinkins, Peter Hall, Andrew Evans
PMCID: PMC13200029  PMID: 42116552

Abstract

BACKGROUND

Annual surveillance mammograms for an unspecified period, after treatment for early breast cancer, are widely practised in the United States of America and Europe. Current UK guidelines recommend annual mammograms for 5 years, then reverts to 3-yearly screening. The aim of this trial was to evaluate whether less than annual mammography was non-inferior in terms of breast cancer-specific survival and cost-effectiveness in women aged 50 years or older at diagnosis and 3 years post curative surgery.

METHODS

We conducted a multicentre, randomised phase III trial of annual mammography versus less-frequent mammography (2-yearly after conservation surgery or 3-yearly after mastectomy). Women were eligible if aged ≥ 50 years at initial diagnosis of breast cancer (invasive or ductal carcinoma in situ) and recurrence-free 3 years post curative surgery. The trial was conducted at 114 NHS hospitals in the UK. Participants were randomly assigned (1 : 1) to annual or less-frequent mammograms; followed up for 6 years. Coprimary outcomes were breast cancer-specific-survival and cost-effectiveness; secondary outcomes included recurrence-free interval and overall survival. Analyses were by intention to treat, with a pre-planned per-protocol analysis. Planned sample size was 5000. Clinical results are now reported.

RESULTS

Five thousand two hundred and thirty-five women were randomised between April 2014 and September 2018. With a median of 5.7-year follow-up, 343 women have died, of whom 116 died of breast cancer (61 on annual arm; 55 on less-frequent arm). Breast cancer-specific-survival at 5 years was 98% on both arms with a hazard ratio of 0.92 (95% confidence interval 0.64 to 1.32), which demonstrated non-inferiority of less-frequent mammograms at the 3% margin (non-inferiority p < 0.0001) and the 1% margin (non-inferiority p = 0.003). Non-inferiority was demonstrated at the 2% level for both recurrence-free interval [hazard ratio 1.00 (95% confidence interval 0.83 to 1.28); non-inferiority p = 0.0024] and overall survival [hazard ratio 1.07 (95% confidence interval 0.87 to 1.33); non-inferiority p = 0.008]. Less-frequent mammograms were associated with a significant cost saving (mean difference £544, 95% confidence interval -£1116 to £26), heavily driven by mammogram costs. Incorporating societal costs resulted in a larger cost-saving (£1543 per person, 95% confidence interval -£2416 to -£669), increasing cost-effectiveness. There was no impact of less-frequent mammograms on patients' quality of life.

CONCLUSION

For patients aged ≥ 50 years and 3 years post diagnosis, less-frequent mammograms were non-inferior and cost-effective compared with annual mammograms, with no detriment to patients' quality of life. Mammo-50 provides evidence to inform guideline development.

LIMITATIONS

Adherence to the mammographic schedules was 76%, though the per-protocol analysis showed no difference compared to the intention to treat results. The majority of the participants had small lower-grade oestrogen receptor-positive tumours and were from a White ethnic group.

FUTURE WORK

More research is needed for women with ductal carcinoma in situ; women aged under 50 years old at diagnosis and different ethnic groups, especially those women of Black ethnicity who tend to present younger.

FUNDING

This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 11/25/03.

Plain language summary

Mammo-50 study was for women with early-stage breast cancer, (i.e. cancer that has not spread to other parts of the body), aged ≥ 50 years at the time of their diagnosis. Following surgery (either a mastectomy or a lumpectomy), women with this type of breast cancer are often followed up with yearly mammograms for an unspecified period of time. Mammo-50 looked at whether it would be safe to have mammograms less frequently. Women were enrolled 3 years after having breast cancer surgery and were free from cancer. They were randomised to receive either yearly or less-frequent mammograms (every 2 years in patients who had a lumpectomy, and every 3 years in patients who had a mastectomy). They were asked to complete regular quality-of-life questionnaires up to 7 years from entering the study. Five thousand two hundred and thirty-five women took part in the study. The percentage of the women taking part who had not died from breast cancer over a 5-year follow-up period was 98.1% for patients having yearly mammograms and was 98.3% for patients having less-frequent mammograms. The percentage of the women taking part who had been diagnosed with a recurrence of their breast cancer over a 5-year follow-up period was 5.9% for patients having yearly mammograms and was 5.5% for patients having less-frequent mammograms. In this study, the women who had less-frequent mammograms were no worse off than the women having yearly mammograms. We also found that having less-frequent mammograms did not impact the quality of life of these women. Offering less-frequent mammograms also reduced costs and workload for the National Health Service. The findings will inform national guidelines about the best way to follow up this population of women.

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