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Spots Global Cancer Trial Database for A Study to Evaluate Denosumab in Young Patients With Primary Breast Cancer

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Trial Identification

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

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

Study ID: NCT01864798

Interventions

Denosumab

Study Description

Brief 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

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Royal Melbourne Hospital, Victoria, , Australia

Institute Jules Bordet, Brussels, , Belgium

Hopital Erasme, Brussels, , Belgium

UZ Leuven, Leuven, , Belgium

CHU Ambroise Paré, Mons, , Belgium

CMSE, Namur, , Belgium

Contact Details

Name: Martine J Piccart, Prof.

Affiliation: Jules Bordet Institute

Role: STUDY_CHAIR

Name: Christos Sotiriou, MD

Affiliation: Jules Bordet Institute

Role: PRINCIPAL_INVESTIGATOR

Name: Hatem Azim, MD

Affiliation: Jules Bordet Insitute

Role: PRINCIPAL_INVESTIGATOR

Name: Sherene Loi, MD,PhD

Affiliation: Melbourne Health

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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