EndoNET
Research type
Research Study
Full title
Randomised controlled trial evaluating effectiveness of neoadjuvant endocrine treatment in post-menopausal women
IRAS ID
1005155
Contact name
Michael Douek
Contact email
Sponsor organisation
University of Oxford
Eudract number
2022-000582-40
ISRCTN Number
ISRCTN11896599
Research summary
There are 50,000 people who develop breast cancer each year in the United Kingdom, mostly women after their menopause and of a type known as oestrogen-receptor positive, HER-2 (human epidermal receptor-2) negative. The current usual standard treatment is surgery within a month of diagnosis, followed by radiotherapy for some where required, and anti-hormone therapy (known as endocrine treatment; ET) for 5-10 years. Most post-menopausal patients with early breast cancer will not require chemotherapy. Almost one half will be treated by surgical removal of the breast (mastectomy). For others, lumpectomy (breast conservation surgery), enables a more limited amount of breast tissue to removed and breast preservation.
ET after surgery is very effective in the long-term treatment of breast cancer; it is however currently unknown whether it is also beneficial to start this same ET before surgery, known as neo-adjuvant endocrine therapy (NET). This study is to determine whether giving some of the ET before surgery will shrink the tumour prior to operating. This could increase the rates of breast preservation by reducing the number of mastectomies for some women and the extent of surgery for others (removing less tissue leaves less defect).
After mastectomy many patients do not want or are unsuitable for breast reconstruction. Even if received, this may not always fully compensate for breast removal. If it is shown that NET reduces the amount of breast tissue that has to be removed and increases the rates of breast preservation, this would be anticipated to improve cosmetic outcomes, leading to better quality of life. This study therefore compares the traditional order of surgery within a month, to a period of ET followed by surgery. The trial aims to recruit 1,440 women from at least 30 NHS hospitals across the UK. Patients in both arms will complete QoL questionnaires at intervals during their 15-month participation and rates of breast conservation will be documented.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
22/EM/0086
Date of REC Opinion
3 May 2022
REC opinion
Favourable Opinion