Registration number(s) / identifiers:

Scientific title

A pre-operative window study evaluating the biological effects of the RANK-Ligand (RANKL) inhibitor Denosumab on normal breast tissue from BRCA1 and BRCA2 mutation carriers

Summary of trial and patient characteristics

Stream(s) Breast
Recruitment status Recruiting
Trial type Prevention
Phase Not applicable
Sex Female
Age range 18 to 50 years
Menopausal status Pre-menopausal
Molecular target RANKL


Breast cancer type All (Unknown/Not applicable)
Stage All (Unknown/Not applicable)
Surgical treatment All (Unknown/Not applicable)
Oestrogen receptor status All (Unknown/Not applicable)
Progesterone receptor status All (Unknown/Not applicable)
HER 2 status All (Unknown/Not applicable)
Gene carrier BRCA 1, BRCA 2

Trial summary

This study will determine the effects of Denosumab on normal breast tissue in women with BRCA1 and BRCA2 mutations. Who is it for? You may be eligible to join this study if you are a pre-menopausal woman aged between 18 years to 50 years and have documented BRCA1 or BRCA2 mutation considering prophylactic mastectomy, OR willing to undergo two breast biopsies on separate occasions. Study details This is a proof-of-concept pilot study to determine if short-term treatment with Denosumab is a feasible chemoprevention option against breast cancer for BRCA1 and BRCA2 mutation carriers. All women participating in the study will receive 4 doses of 120mg per dose of Denosumab subcutaneously (injected into the skin) over three months (monthly dose plus an extra dose at day 15 for the first month). Women will then proceed to their surgery as planned, or have their second breast biopsy. Participants will be followed up for up to 1 month after the last treatment dose.

General information about this or other trials

Click here to ask a nurse

Other non-commercial sponsor

Royal Melbourne Hospital

Participating hospitals

HospitalSuburb / TownContact nameEmailPhoneRecruitment status
PCCTU (Parkville cancer clinical trials unit) * Parkville Ms Marian Lieschke 03 8559 7140 Recruiting

[ X Close ]