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  • EMBRACE

    Acronym: 

    EMBRACE

    ACTRN/NCT /ethics: 

    ACTRN12617000855325

    Scientific title: 

    A clinical research study testing olaparib, in Homologous recombination (HR) deficient metastatic breast and relapsed ovarian cancer in patients who do not have hereditary mutations in BReast CAncer susceptibility gene 1 and gene 2 (BRCA1 and BRCA2)

    Summary of trial and patient characteristics

    Cancer Type Breast, Gynaecological
    Trial Type Treatment
    Phase Phase II Tumour Stream Breast/Ovarian
    Age Range 18 years and older Cancer Stage Locally Recurrent or Locally Advanced, Metastatic or Widespread
    Sex Female Anticipated Start Date 2017-11-30
    Molecular Target Anticipated End Date 2020-10-31
    Cancer Type Breast, Gynaecological
    Trial Type Treatment
    Phase Phase II
    Age Range 18 years and older
    Sex Female
    Molecular Target
    Tumour Stream Breast/Ovarian
    Cancer Stage Locally Recurrent or Locally Advanced, Metastatic or Widespread
    Anticipated Start Date 2017-11-30
    Anticipated End Date 2020-10-31

    Trial Summary

    This study is testing olaparib, in Homologous recombination (HR) deficient metastatic breast and relapsed ovarian cancer in patients who do not have hereditary mutations in BReast CAncer susceptibility gene 1 and gene 2 (BRCA1 and BRCA2). Who is it for? You may be eligible to join this study if you are aged 18 years or above and are either: a) men or women with confirmed evidence of metastatic triple negative breast cancer OR b) women with confirmed evidence of relapsed high grade serous ovarian cancer or high grade endometrioid ovarian cancer Study details All study participants will take olaparib 300 mg orally twice daily until disease progression or unacceptable toxicity. Assessments for safety and efficacy will be followed up for a minimum of 6 months Olaparib, has been approved overseas and in Australia in women shown to have inherited changes in their BRCA1 or 2 genes. There is strong evidence to show that olaparib will also work in people who do not have any changes in their genes. The purpose of this study is to assess whether the olaparib is effective in treating these tumours.

    Lay Summary

    A clinical research study testing olaparib, in Homologous recombination (HR) deficient metastatic breast and relapsed ovarian cancer in patients who do not have hereditary mutations in BReast CAncer susceptibility gene 1 and gene 2 (BRCA1 and BRCA2)

    Sponsor / Cooperative group

    ANZGOG

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Royal Adelaide Hospital Anne Milton anne.milton@sa.gov.au 08 7074 2342 Professor Nick Murray Recruiting