Breast Neoplasms Clinical Trial
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
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
n/a
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