Study name: Enabling the study of metabolism in breast cancer through collection of fresh-tissue biopsies
The ENSEMBLE study aims to evaluate how breast cancer cells utilise nutrients to grow. Often, cancer cells will use different nutrients to healthy cells in order to grow, or they will use the same nutrients but in an altered way. The behaviour of individual cancers seems to be influenced by how they are able to process these nutrients, as previous studies have already shown that if breast cancer cells cannot access specific nutrients, they cannot grow. Understanding more about this in individual tumours may allow us to identify new treatment targets and improve breast cancer treatment in the future. This is what the ENSEMBLE study is hoping to address.
Patients who are consented and enrolled into the ENSEMBLE study will receive up to two additional ‘research biopsies’ (depending on what their treatment plan is). Patients who are intended to receive treatment before their main surgery (this is called neo-adjuvant treatment) will receive a research biopsy both before their neo-adjuvant treatment starts and then again, at the time of surgery (intra-operatively). Patients who will not be having neo-adjuvant treatment will only receive one research biopsy at the time of surgery. The research biopsy procedure is exactly the same as the one that patients have as part of the standard of care (in order to inform a cancer diagnosis) and is only called a ‘research biopsy’ as it is an additional procedure, purely for research purposes. Each research biopsy will aim to collect up to (but no more than) four ‘cores’ (tissue samples) of breast tumour tissue per biopsy, which will then be analysed to look for patterns in the cancer cell metabolism. Some of the analysis for this study will also involve the use of mice as a model for human cancer, which have been specifically bred in a laboratory for research purposes. All work with mice will comply with the legislation surrounding the use of laboratory animals in research.
The Primary outcome (objective) is the successful collection of biopsies.
The secondary outcome is understanding how specific ‘events’ that work in favour of breast cancer cells, alter their metabolism to allow them to grow uncontrollably. This is to allow the team to identify areas of weakness in cancer cell metabolism, with a view to identifying new targets for cancer therapies (treatments).
The study will be carried out at 6 hospitals in the UK:
- University College London Hospitals NHS Foundation Trust (UCLH)
- Royal Free London NHS Foundation Trust
- Whittington Health NHS Trust
- Barts Health NHS Foundation Trust
- Guy’s and St Thomas’s NHS Foundation Trust
- King’s College Hospital NHS Foundation Trust
The study aims to enrol 240 patients into the study across the 6 sites mentioned above. Once the patients have had their research biopsy/ biopsies, they will return to the standard of care, and are not required to complete any further activities specifically for the study. They will then be followed up remotely via NHS digital (national health registries) for clinical outcome data and to clarify information about medical history.
Sponsor: University College London
Funder: Cancer Research UK (CRUK) & Wellcome Trust
Clinicaltrial.gov identifier: NCT03880097