The ZOLMENO study
Research type
Research Study
Full title
The role of ZOLedronic acid and MENOpausal status on the tumour and bone microenvironment in patients with early breast cancer: a single centre, randomised, proof of concept clinical study.
IRAS ID
197918
Contact name
Janet E Brown
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Eudract number
2015-005713-67
Duration of Study in the UK
3 years, 2 months, 1 days
Research summary
Why does the effect of ZOLedronic acid in early breast cancer patients depend on MENOpausal status? The ZOLMENO study.
In the UK, breast cancer is the most common cancer. Each year 12,000 UK women die from breast cancer, with most having incurable spread to their bones; prevention of which is an important unmet issue for patients and health professionals.
Bisphosphonate drugs, such as zoledronic acid, are commonly used to make bones stronger. Research has shown that if women with early breast cancer are given bisphosphonates then cancer spread to bone is less likely and women are more likely to live longer. However, this benefit was only seen in post-menopausal women, and the reason behind this is unknown.
The ZOLMENO study has been designed to identify how hormone levels affect the way bisphosphonates prevent breast cancer spreading to bone. We hope to then be able to identify which women will get most benefit from bisphosphonate treatment and ways to develop treatments which benefit pre-menopausal women.
40 pre-menopausal and 40 post-menopausal women with early breast cancer will be randomised to receive a 4mg (standard) dose of zoledronic acid either 7 days before or 21 days after breast cancer surgery (comparing any changes between the tumour being present or absent at the time of treatment). Blood samples will be taken at 5 time points over a maximum of 65 days, and when participants are anaesthetised (asleep) for surgery a bone marrow sample (where a narrow needle is inserted into the bone above the buttock) will be taken. There will be an optional further bone marrow sample performed under local anaesthetic. Surplus tumour removed at surgery will also be analysed. This research is funded by Yorkshire Cancer Research, and we will be recruiting over 2 years at Sheffield Teaching Hospitals NHS Foundation Trust.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
16/YH/0151
Date of REC Opinion
13 May 2016
REC opinion
Favourable Opinion