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Pet Imaging as a Biomarker in Hormone Refractory postmenopausaL Women — PEARL  

Breast Cancer Clinical Trial

Official title:
Pet Imaging as a Biomarker of Everolimus Added Value in Hormone Refractory postmenopausaL Women

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02028364
Study type Interventional
Source Jules Bordet Institute
Contact
Status Completed
Phase Phase 2
Start date January 12, 2014
Completion date August 9, 2021
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