MAMMO-50: The results of the pre-planned internal 2 year feasibility study for Mammographic surveillance in early breast cancer patients over 50 years of age at diagnosis
1Warwick Clinical Trials Unit, Coventry, UK,2South Devon Healthcare NHS Foundation Trust, Torquay, UK,3Independent Cancer Patient Voices, London, UK,4Department of Clinical Healthcare, Oxford Brookes University, Oxford, UK,5St James’s University Hospital, Leeds, UK,6University Hospital of South Manchester NHS Foundation Trust, Manchester, UK,7Ninewells Medical School, Dundee, UK
There is no clear evidence or consensus amongst surgeons on the optimum frequency or duration of follow-up and mammographic surveillance for early breast cancer patients who are 50 years and older at diagnosis. Mammo-50 aims to investigate frequency and duration questions whilst exploring alternative follow-up strategies. A pre-planned internal 2 year feasibility study has assessed acceptability of the trial and user perspectives. Quality of life (QoL) and patient reported outcome measures (PROMs) were also collected with the aim of identifying which questions to collect in the main trial.
Mammo-50 is a multicentre, randomised controlled, phase III trial of annual mammography versus 2 yearly for conservation surgery and 3 yearly for mastectomy patients. There is also a linked observational cohort study of those eligible patients for whom the surgeon or patient opts for continued mammographic surveillance as per local practice. Patients are randomised 3 years after surgery.
To date (31st May 2015) 843 patients (69%) have been randomised between the two arms and 371 patients (31%) have entered the cohort study. 82 sites are open to recruitment with an additional 17 in set-up, which indicates the target of 100 centres will be met. Of patients randomised, 74% have undergone conservation surgery, 89% have invasive disease, 82% aged 55-75 years, 83% ER +ve and 73% undergoing hormone therapy. Focus groups were undertaken, exploring experiences and perceptions of the trial and follow-up options (e.g. telephone, written or internet contact). Altruism was a common reason for entering the trial. Preliminary analysis of the QoL and PROM data indicate that 29% patients have raised level of distress with fatigue, sleep, memory/concentration, pain and itchy/dry skin reported as the more common problems.
Mammo-50 is an acceptable trial to patients and clinical teams. The findings from the feasibility phase demonstrate patients are willing to be entered into the study. The PROMs and QOL gathered within the feasibility phase demonstrate that 29% of early breast cancer patients 3 years post-surgery report distress.