The EndoNET Trial
Neo-adjuvant endocrine treatment (NET) for post-menopausal women with breast cancer
Specialty: Breast cancer, breast surgery
Status: Open to Recruitment
Welcome to EndoNET, a clinical trial designed to understand if a period of treatment with hormone therapy prior to surgery reduces the requirement for mastectomy and improves quality of life in post-menopausal women.
EndoNET was identified as a research priority by NICE for post-menopausal women with early breast cancer and the trial is driven by our patient advocates including Independent Cancer Patients’ Voice.
EndoNET is a Phase III, multi-centre trial that evaluates whether endocrine treatment that prevents the production of oestrogens, when taken for 6 months prior to surgery, will shrink the tumour allowing for a reduction in the extent of surgery.
To be considered for the study, patients must be:
- Strongly ER+
- Tumour > 20 mm.
Participants will either be randomised to surgery at 2-4 weeks (up to 8 weeks permitted) or 6 months (+/- 1 month). Participants will complete quality of life questionnaires at intervals during their 15-month participation and rates of breast conservation surgery will be documented.
Eligible patients will either be randomised to either surgery at 2-4 weeks (up to 8 weeks permitted) or 6 months (+/- 1 month). Participants will start their endocrine treatment (aromatase inhibitors: letrozole, anastrozole or exemestane) after being randomised:
The endocrine treatment offered in both arms is the same but the timing of surgery differs. This is to see if a longer duration of endocrine treatment before surgery will shrink the tumour to allow for less extensive surgery.
If you are a UK hospital who would be interested in joining the 30+ centres taking part in EndoNET, please contact: email@example.com to find out more information and request a feasibility form. We are part of the NIHR Associate PI scheme and are on the NIHR Portfolio.
Prof. Michael Douek
Prof. Ramsey Cutress
EndoNET is funded by the National Institute for Health Research HTA Programme.
Visit us on the Association for Breast Surgery website.