BRCA-P
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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
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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).
INCLUSION
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BRCA1 germline mutation
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Aged ≥ 25 to ≤ 55 years
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No evidence of breast or ovarian cancer
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No preventive breast surgery (mastectomy) planned
EXCLUSION
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History of breast or ovarian cancer
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Prior bilateral mastectomy
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Pregnant or lactating women
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For more information visit Breast Cancer Trials Breastolution page or contact transbcr@wehi.edu.au​