Breast Cancer Clinical Trial
Official title:
Pre-surgical Evaluation of Denosumab in Patients With Operable Invasive Breast Cancer
The purpose of this study is to determine whether one dose of denosumab can lead to changes in the tumor, which may decrease the ability of tumor to spread.
Breast cancer is the most common cancer among women, affecting one in eight women, and is the
second leading cause of mortality from cancer. Bone metastases are a frequent complication of
breast cancer, and the mechanism of breast cancer metastases to bone is an ongoing area of
research.. Receptor activator of NF-kB (RANK) and its ligand (RANKL) have been identified and
characterized for its role in bone remodeling. RANKL is a member of the tumor necrosis factor
(TNF) family of cytokines that binds to its receptor RANK to control osteoclast
differentiation, activation, and survival. RANK protein expression is not only found on
osteoclasts and dendritic cells but also on T cells and mammary epithelial cells. RANK and
RANKL is important for lymph node and thymus formation as well as lactating mammary gland
development during pregnancy. Furthermore, the RANK/RANKL axis has been linked to progestin
driven breast carcinomas and bone metastases.
RANK is expressed in 6-57% of invasive human breast cancers (depending upon the parameters
for defining positivity and antibodies utilized for immunohistochemistry (IHC)), and RANKL
driven hormone (progesterone -dependent proliferation, survival, and nonproliferative
expansion of mammary stem cells may contribute to breast cancer initiation, progression, and
recurrence.
We hypothesize that denosumab can inhibit RANKL signaling in early breast tumors which
express RANK, inhibiting pro-metastatic mechanisms and reducing immunosuppression in the
tumor microenvironment. This will be tested in a pre-surgical clinical trial (Phase 0) to
evaluate and select the pharmacodynamics markers of RANKL inhibition in breast cancer.
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