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