Inclusion criteria, exclusion criteria and study summary
• Female,• Clinically post-menopausal; including one of: o amenorrhoea > 12 months and an intact uterus. o bilateral oophorectomy o for those with a history of hysterectomy,or HRT within 12 months,venous FSH levels classified as post-menopausal by the testing laboratory if any doubt. • Unifocal,newly diagnosed breast cancer visible on USS; • Strongly ER+; defined as Allred scores of 7 or 8 or equivalent • HER2- by immunohistochemistry,or 2+ and not amplified by in situ hybridisation • T-stage 2 or 3 (> 2cm); • Axillary N0-1 on diagnostic USS +/- negative FNA or core biopsy; • Suitable for surgery and radiotherapy; • Chemotherapy unlikely to be indicated; • Participant is able and willing to give informed consent for participation in the trial; • In the Investigator’s opinion,is able to comply with all trial requirements.
• Bilateral breast cancer; • ER- or HER2+; • Stage IV disease (distant metastasis); • Previous neoadjuvant treatment for breast cancer; • Previous invasive malignancy within 5 years other than basal cell carcinoma; • Concurrent use (at the time of randomisation) of HRT or any other oestrogen-containing medication (including vaginal oestrogens); • Ovarian suppression/ablation for the purposes of trial entry not permitted.
RESEARCH QUESTION: In post-menopausal women who will not require chemotherapy for >T1,strongly ER+,HER2- invasive breast cancer,does NET improve global HRQoL over 15 months and increase breast BCS rates? Patients will be randomised 1:1 to either the intervention (NET) arm (6 +/- 1 months of NET followed by surgery and adjuvant ET) or the control arm (2-4 weeks of presurgical NET and surgery within 2-4 weeks [up to 8 weeks permitted for trial purposes] followed by adjuvant ET). Both arms will receive the same treatments (surgery,ET,and radiotherapy where indicated),but the sequencing of surgery will differ; both arms starting ET at randomisation,with 6 months +/- 1 month of the course of ET delivered prior to surgery in the NET arm.
