NCT01864798

A Study to Evaluate Denosumab in Young Patients With Primary Breast Cancer

A Pre-Operative Window Study Evaluating Denosumab, a RANKligand (RANKL) Inhibitor and Its Biological Effects in Young Premenopausal Women Diagnosed With Early Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Jules Bordet Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single arm phase IIa trial in which patients with early breast cancer will receive pre-operatively two doses of denosumab 120mg subcutaneously one week apart (maximum 12 days) followed by surgery. Tumor, normal breast tissue and blood samples will be collected at baseline and at surgery. Post-operative treatment will be at the discretion of the investigator. Primary objective: to determine if a short course of RANKL inhibition with denosumab can induce a decrease in tumor proliferation rates as determined by Ki67 immunohistochemistry (IHC) in newly diagnosed, early stage breast cancer in pre-menopausal women. Secondary objectives: * To determine the number of absolute Ki67 responders after a short course of denosumab (defined as \<2.7% IHC staining in the post treatment tumor biopsy). * To determine the effects of a short course of denosumab on serum C-terminal telopeptide levels (CTX). * To determine the effects of a short course of denosumab on RANK/RANKL gene expression and signaling as assessed by immunohistochemistry (IHC) and RNA sequencing in the tumor. * To determine the effect of a short course of denosumab on tumor apoptosis rates using IHC * To determine the effect of a short course of denosumab on modulating the immature mammary epithelial cell populations in the tumor. * To determine the effect of a short course of denosumab on estrogen signaling pathways in the tumor. * To determine the effect of a short course of denosumab on various immune * To determine effect of safety profile of denosumab

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
DRUG	Denosumab

Timeline

• Start date: 2013-07-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2013-05-30
• Last updated: 2018-11-27

Locations

6 sites across 2 countries: Australia, Belgium