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

NCT01864798 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2018-11-27

No results posted yet for this study

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

DRUG

Denosumab

Sponsors & Collaborators

  • Melbourne Health

    collaborator OTHER

  • Jules Bordet Institute

    lead OTHER

Principal Investigators

  • Martine J Piccart, Prof. · Jules Bordet Institute

  • Christos Sotiriou, MD · Jules Bordet Institute

  • Hatem Azim, MD · Jules Bordet Insitute

  • Sherene Loi, MD,PhD · Melbourne Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • Australia
  • Belgium

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01864798 on ClinicalTrials.gov