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
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.
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Royal Melbourne Hospital
|Hospital||Suburb / Town||Contact name||Phone||Recruitment status|
|PCCTU (Parkville cancer clinical trials unit) *||Parkville||Ms Marian Lieschkefirstname.lastname@example.org||03 8559 7140||Recruiting|
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