A phase II, multicentre, randomised study to compare the efficacy of venetoclax plus fulvestrant as a combination treatment for locally advanced or metastatic ER-positive breast cancer.
About this study
This research project is testing a new treatment for locally advanced or metastatic ER-positive breast cancer. The new treatment is called venetoclax given in combination with fulvestrant and we want to know whether adding venetoclax will add to the effectiveness of the fulvestrant.
Fulvestrant is a drug that is designed to bind to the oestrogen receptors, completely blocking the ability of oestrogen to attach to these receptors. This can help to slow down the growth of ER-positive breast cancer.
Venetoclax has been approved for treatment of a type of leukaemia. In this study, venetoclax is an experimental drug, which means health authorities have not approved it in combination with fulvestrant for the treatment of ER-positive breast cancer.
Who can take part
- People with oestregen receptor (ER-positive) locally advanced or metastatic breast cancer
- Metastatic disease measurable on scan
- No more than 2 previous types of hormone therapy for metastatic disease
- Previous treatment with palbociclib or another CDK4/6 inhibitor
- Previous treatment with fulvestrant is an exclusion
Screening (to see if this research project is suitable for you)
- Blood, pregnancy and hepatitis tests
- Urine sample
- CT or MRI or x-ray (to assess tumour)
- Provide tissue sample of tumour
Treatment and follow-up (if eligible)
- Injections and/or tablet
- In cycle 1, you will have several visits
- After cycle 1, one visit every 4 weeks
- Urine samples, blood tests, general health information
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.
The Clinical Trials Centre (CTC) is a dedicated, purpose-built space where we conduct clinical trials.
The CTC is located on Level 2 South. When you arrive, if you are unsure where to go, talk to one of our friendly volunteers or the information desk staff.