NeoSTEM
Research type
Research Study
Full title
NeoSTEM: a pilot trial examining predictors of chemotherapy response in the NEOadjuvant setting using a STEM cell signature in Triple Negative Breast Cancer (TNBC)
IRAS ID
255490
Contact name
Tim Robinson
Contact email
Sponsor organisation
University of Bristol
Duration of Study in the UK
2 years, 3 months, 1 days
Research summary
Triple Negative Breast Cancer (TNBC) is the most aggressive type of breast cancer for which chemotherapy is the only systemic treatment option. Previous research has shown that response and resistance to chemotherapy treatment around the time of breast surgery can predict prognosis but there are currently no tests that can detect who will respond to treatment. However, a stem cell gene expression signature that we believe could be used to predict response has been identified. In this study we will capture this signature in both breast cancer tissue and circulating components of tumour cells (called exosomes) at various points in a patient's treatment to detect any resistance developing.
This pilot study will test the feasibility of this approach and indicate whether it warrants further clinical trials. We aim to recruit 20 patients having treatment for TNBC with chemotherapy before surgery (neoadjuvant chemotherapy) in two cancer treatment centres (North Bristol NHS Trust and UH Bristol NHS Foundation Trust) and analyse the tissue taken routinely at the time of biopsy before chemotherapy and surgery after chemotherapy to profile the gene expression signature in their breast tumours. We will also collect blood samples at the same time as routine blood tests at 7 points through chemotherapy treatment to assess changes in the same gene expression signature and changes in the exosomes themselves.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
19/NW/0033
Date of REC Opinion
23 Jan 2019
REC opinion
Favourable Opinion