Seeking participants for a breast cancer prevention trial

A clinical trial to assess whether Denosumab can prevent breast cancer in women with a BRCA1 mutation

The purpose of this research is to find out whether the study medication denosumab can help prevent breast cancer in women with a BRCA1 mutation. The research also aims to find out whether denosumab decreases the risk of developing ovarian cancer or other types of cancer, study the safety of using denosumab, and study its effect on bone health.

The study is a randomised, double-blind, placebo-controlled study.  This means that participants will receive an injection of either denosumab or placebo (no drug) every 6 months for 5 years. Participants will need to visit their study doctor every 6 months while receiving the medication and will continue to be checked by their study team every 12 months for a further 5 years (total of 10 years).

Anticipated date that enrolment will close: September 2021

Who can take part

Inclusion criteria

  • Women with the BRCA1 mutation
  • Aged between 25 and 55 years
  • No evidence of breast or ovarian cancer
  • No preventive breast surgery (mastectomy) planned

Exclusion criteria

  • People with a history of breast or ovarian cancer
  • People with both breasts removed (double mastectomy)
  • Pregnant or lactating women

What is involved for you

  • Breast MRI
  • Bone density scan
  • Blood tests at each visit
  • Quality of life questionnaires at various intervals
  • Injection of either denosumab or the placebo every 6 months for 5 years
  • Follow-up visits once every 12 months for 5 years
check
Non-Drug
Phase 1
Phase 2
Phase 3
Phase 4

For more information

Quote reference number
2019.196
Breast Trials Team
(03) 8559 5088