None listed
Conditions
Brief summary
The purpose of this study is to improve the outcome of breast cancer patients who develop brain metastases. This will investigate the benefits of early detection of brain metastases using brain imaging. In patients diagnosed and currently being treated for advanced or metastatic breast cancer, current guidelines do not recommend routine brain imaging. Who is it for? You may be eligible to participate in this study if you are a female age 18 or over with diagnosed with metastatic breast cancer, ER-positive disease after second-line therapy and CDK4/6 inhibitors, plus more than two sites of bone metastasis or visceral metastasis as well as triple negative (TNBC) and human epidermal growth factor-2 positive (HER-2) patients. Study details Study participants will be screened for brain metastases using Computerised Tomography (CT scans) and patients will have 3 monthly CT scans of the brain for 2 years and then 6 monthly for 2 years. This will be organised by the oncology team and will last around 20 minutes for the procedure and will be undertaken by the radiographers in imaging units in collaboration with the radiologists, Throughout the study’s period, participant’s medical records and CT scan results will be reviewed and compared to historical data. It is hoped that the result from this study will help to determine whether routine brain imaging should be offered to patients with breast cancer.
Interventions
Screening for brain metastases using Computerised Tomography (CT scans).
The patients will have 3 monthly CT scans of the brain for 2 years and then 6 monthly for 2 years. This will be organised by the oncology team and will last around 20 minutes for the procedure and will be undertaken by the radiographers in imaging units in collaboration with the radiologists. These will happen at the time of the routine scans undertaken at the time other scans are done to evaluate response to treatment. The
Screening for brain metastases using Computerised Tomography (CT scans). The patients will have 3 monthly CT scans of the brain for 2 years and then 6 monthly for 2 years. This will be organised by the oncology team and will last around 20 minutes for the procedure and will be undertaken by the radiographers in imaging units in collaboration with the radiologists. These will happen at the time of the routine scans undertaken at the time other scans are done to evaluate response to treatment. The clinical trials team will, ensure that the scans are carried out at the appropriate times and monitored when in the study.. The patient will be in the study for 4 years.
Sponsors
Monash University
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Metastatic breast cancer with visceral, nodal or bone metastasis • Human Epidermal Growth Factor Receptor 2-positive disease - Triple Negative disease with metastatic disease -Oestrogen Receptor Positive disease after second-line therapy and cyclin dependent kinase (CDK) 4/6 inhibitors, plus more than two sites of bone metastasis or visceral metastasis - Diagnosis of metastatic disease in the last 3 months and free of symptoms or disease (with brain Magnetic Resonance Imaging confirmation) - Medicare Eligible
Exclusion criteria
-symptomatic brain metastasis -inability to provide consent -inadequate organ function -pregnancy.
Outcome results
None listed