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A trial investigating how effective endocrine treatment is, prior to surgery in post-menopausal women with breast cancer, has randomised its first patient of the year.

The EndoNET trial team, investigators and research nurses.

Over 50,000 women develop breast cancer each year in the UK. The current standard of care is surgery within a month of diagnosis, followed by radiotherapy for some, and anti-hormone therapy (known as endocrine treatment) for 5-10 years. Over 40% of patients will be treated by surgical removal of the breast, while others may require surgery where only a limited amount of tissue is removed (breast conservation surgery).

Endocrine treatment after surgery is very effective in the long-term treatment of breast cancer; but it is unknown whether starting this same endocrine treatment before surgery, known as “neo-adjuvant endocrine therapy”, is also beneficial. The EndoNET trial, led by Professor Michael Douek and Professor Ramsey Cutress, is run by the Surgical Intervention Trials Unit (Nuffield Department of Surgical Sciences) and seeks to evaluate whether six months of endocrine treatment before surgery can shrink the tumour prior to operating, which could reduce the extent of breast surgery required.

The trial’s first patient of 2023 was successfully randomised on 3rd January at St Albans City Hospital. EndoNET aims to recruit a total of 1,440 women from 30+ hospitals across the UK, and is being led by the University of Oxford in collaboration with investigators at the University of Southampton and the University of Bristol.

Commenting on EndoNET’s early recruitment success, Lead Investigator Professor Cutress of the University of Southampton said:

“We are absolutely thrilled that the trial has opened and patients from a number of sites have already taken the opportunity to participate. EndoNET is a national, multicentre, randomised controlled clinical trial funded by the National Institute for Health Research. It is designed to understand if a period of treatment with hormone therapy prior to surgery reduces the requirement for mastectomy and improves quality of life. This is important to patients, and was identified as a research priority by NICE, so it’s fantastic that this research is now up and running.”

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