Pet Imaging as a Biomarker in Hormone Refractory postmenopausaL Women
Status:
Unknown status
Trial end date:
2020-01-01
Target enrollment:
Participant gender:
Summary
This is a prospective, single arm trial in which patients with locally advanced or metastatic
endocrine receptor positive and HER2 negative breast cancer refractory to non-steroidal
aromatase inhibitors (NSAI) will receive Everolimus 10mg orally daily given in conjunction
with exemestane 25mg orally daily until disease progression or treatment discontinuation for
any other reasons. The main objectives are to evaluate if early metabolic response (MR) using
FDG-PET/CT is associated with progression free survival (PFS) and overall survival (OS) in
this population.
Tumour, metastatic lesions and blood samples will be collected during the treatment period in
order to identify biomarkers predicting resistance to study treatment. Results will be
correlated with the results of early FDG PET/CT data in order to better characterise the
non-responders.