NCT02028364

Pet Imaging as a Biomarker in Hormone Refractory postmenopausaL Women

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Jules Bordet Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Everolimus	10mg orally daily
DRUG	Exemestane	25mg orally daily

Timeline

• Start date: 2014-01-12
• Primary completion: 2021-07-06
• Completion: 2021-08-09
• First posted: 2014-01-07
• Last updated: 2023-08-24

Locations

5 sites across 1 country: Belgium