Denosumab as an add-on Neoadjuvant Treatment (GeparX)
Status:
Completed
Trial end date:
2020-12-31
Target enrollment:
Participant gender:
Summary
Pharmacologic inhibition of RANKL attenuates the development of mammary carcinoma and
inhibits metastatic progression in multiple mouse models.
In a retrospective analysis it could be demonstrated that elevated expression of RANK was
found in 14.5% of patients overall, with a significant predominance in patients with
hormone-receptor-negative disease. Expression of RANK was associated with a higher
pathological complete response rate but with a shorter disease-free and overall survival. The
ABCSG-18 study showed that adjuvant denosumab reduces clinical fractures, improves bone
health, and can be administered without added toxicity.
It appears therefore reasonable to test denosumab, a clinically available antibody against
RANKL in patients with hormone-receptor-negative primary breast cancer as an adjunct to
neoadjuvant chemotherapy for its ability to increase pCR rate and improve outcome in relation
to the expression of RANK.