Overview
This study is now closed
One third of all UK breast cancers occur in women over the age of 70 but outcomes are inferior to those of younger women. This is partly due to later presentation but also the often non-standard treatment older women receive. Rates of surgery, radiotherapy and chemotherapy are all lower in older women. Treatment protocols are often modified to reduce the risk of side effects which are more common in frailer older women. However there is no scientific basis for where treatment cut-offs should be. At what age/level of fitness or frailty is standard treatment more likely to cause harm than benefit. The Age Gap study is a multicentre observational cohort study of older women with early breast cancer. Over 3000 women will be recruited. The complex data on health/fitness, cancer stage/type and treatment will be analysed using complex data modelling to define criteria to optimise treatment. A series of decision support interventions are also being trialled within the study.
Aims
- To determine the patient and cancer characteristics which predict whether Primary Endocrine Therapy (PET) is a safe and effective breast cancer treatment in older women with ER+ breast cancer by means of statistical modelling based on both retrospective registry data, HES data and prospective cohort study data.
- To develop a simple scoring system, based on co-morbidity, dependency, age and tumour characteristics, which will enable prediction of those women best treated with PET or surgery.
- To develop a web-based algorithm based on the developed model to aid clinician decision making.
- To evaluate the efficacy of the above on line algorithm and other bespoke decision aids to help older women decide about their treatment choices as part of a cluster randomised trial nested within the main Age Gap study
Inclusion criteria
Female, over 70 years of age with operable breast cancer.
No restriction on cognitive capacity as study is open to recruitment by proxy for women with dementia.
Further information
You can find further information about this trial here.