EndoNET: Randomised controlled trial evaluating effectiveness of neoadjuvant endocrine treatment in post-menopausal women with breast cancer
Overview:
EndoNET is a Phase III, randomised, controlled trial evaluating whether a period of endocrine therapy prior to surgery (neoadjuvant endocrine therapy) reduces surgical burden and better health-related quality of life (QoL) for post-menopausal women with ER+, HER2- invasive breast cancer who do not require chemotherapy.
Objectives:
Primary
To evaluate whether 6 (+/-1) months of neo-adjuvant endocrine therapy reduces surgical burden resulting in better HRQoL over 15 months and higher rates of breast conservation surgery (BCS) for post-menopausal women with >T1, strongly ER+, HER2- invasive breast cancer who do not require chemotherapy.
Secondary
- Disease free survival/recurrence
- Ki67 evaluation in NET setting
- Other surgical outcomes
- Other patient-reported outcome measures (PROMs).
Key inclusion criteria:
- Post-menopausal women
- Unifocal Breast Cancer visible on ultrasound
- Strongly ER+, HER2-
- T-stage 2 or 3 (> 2cm)
- Axillary N0-1 on diagnostic USS +/- negative FNA or core biopsy
- Unlikely to require chemotherapy.
Planned sample size:
1,440 participants (720 per arm) will be randomised (1:1) to either to the comparator arm (pre-surgical ET, surgery at 2-4 weeks) or the intervention arm (NET, surgery at 6 months).
Total number of sites planned:
Approximately 50 sites planned.
EndoNET is open to new sites and would welcome expressions of interest by contacting the study team on endonet@nds.ox.ac.uk.
Timeline:
Planned recruitment period is from August 2022 to June 2025 with a long-term follow up of up to 20 years (subject to additional funding and/or resource).
Contact information and website:
You can contact the study team on endonet@nds.ox.ac.uk or find out more information on our website: https://www.nds.ox.ac.uk/research/surgical-intervention-trials-unit/the-endonet-trial.