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A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, International Phase 3 Study to determine the Preventive Effect of Denosumab on Breast Cancer in Women carrying a BRCA1 Germline Mutation

Recruiting at: Royal Melbourne Hospital and PeterMacCallum Cancer Centre*

Primary Investigator: Professor Geoff Lindeman

National Sponsor: Breast Cancer Trials

Clinical trial register: 2017-002505-35


*see the Breast Cancer Trials website for information about other participating study sites across Australia

Women aged between 25 and 55 years with a BRCA1 germline mutation may be eligible for inclusion in this study. Participants who enrol in this study will be randomly allocated into placebo (no treatment) or denosumab treatment arms for a duration of five years, followed by annual follow-up for 5 years (total study length: 10 years).



  • BRCA1 germline mutation 

  • Aged ≥ 25 to ≤ 55 years

  • No evidence of breast or ovarian cancer

  • No preventive breast surgery (mastectomy) planned



  • History of breast or ovarian cancer 

  • Prior bilateral mastectomy 

  • Pregnant or lactating women 

For more information visit Breast Cancer Trials Breastolution page or contact​

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