None listed
Conditions
Brief summary
The aim of this study is to use whole genome sequencing technology to define the genetic variations present within a breast cancer patient’s tumour, prior to treatment. This information will be used to determine whether we could predict whether different therapies could elicit an improved response should the tumour not respond to the first round of drugs or if it recurs or spreads some time after initial treatment. Who is it for? You may be eligible for this study if you are aged 18 years or older, have been diagnosed with breast cancer, and are planned for treatment via a neo-adjuvant pathway. Study details Prior to starting neoadjuvant therapy, all participants will have a core biopsy taken by a qualified radiologist and give a blood sample. After neoadjuvant treatment is complete, participants will undergo their planned surgery, where a sample of the resected tumour will may be taken (if the treatment has not been completely effective). Samples will be analysed via whole genome sequencing. We will also be analysing patient blood for circulating tumour DNA and circulating tumour cells in order to predict treatment response and recurrence. A detailed health economics analysis will also take place to determine if whole genome sequencing offers a cost effective benefit to patients and the health system. It is hoped that this study will demonstrate that whole genome sequencing technology can be used to identify genetic variations in breast cancer patients that could be targetable by drug therapies. This could help to justify personalising breast cancer therapy based on whole genome sequencing analysis in future.
Interventions
The specified interventions for this trial are:
1. 3 core biopsy samples to be taken at the time of surgical clip insertion by a qualified radiologist. The surgical clip is inserted just prior (typically within a week) to the commencement of neo-adjuvant chemotherapy.
2. Pre treatment blood samples will be taken (3 x 10 ml)
3. Post treatment blood samples will be taken at the completion of chemotherapy (approximately 3-4 months) (2 x10 ml).
4. Surgery at the completion of the treatment will be
The specified interventions for this trial are: 1. 3 core biopsy samples to be taken at the time of surgical clip insertion by a qualified radiologist. The surgical clip is inserted just prior (typically within a week) to the commencement of neo-adjuvant chemotherapy. 2. Pre treatment blood samples will be taken (3 x 10 ml) 3. Post treatment blood samples will be taken at the completion of chemotherapy (approximately 3-4 months) (2 x10 ml). 4. Surgery at the completion of the treatment will be the standard procedure advised by your surgeon.
Sponsors
University of Queensland
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must be diagnosed with a breast cancer that will be treated via a neo-adjuvant pathway.
Exclusion criteria
None
Outcome results
None listed