SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer

This study is looking for both men and women, aged 18 or over, who have breast cancer that has spread. Your cancer should not be HER2-positive. You should generally be fit and well, with a good WHO Performance Status of 0 or 1, and your cancer should have clear areas that can be measured.

You would typically be starting your first or second round of chemotherapy for your metastatic breast cancer, or have recently started and shown a stable condition if on your second round. Doctors will need to be able to take a new biopsy of your cancer, or use an existing one, for genetic testing. If you have bone metastases, other sites of cancer for biopsy are preferred.

If you decide to take part, the first step involves a screening phase where a sample of your tumour (either a new biopsy or an existing frozen sample, or a blood test for circulating tumour DNA) will be sent for detailed genetic analysis. This helps to identify any specific changes in your cancer’s genes. There will be a waiting period while these tests are processed.

If your cancer has responded well to your initial chemotherapy (after 4 to 8 cycles) and the genetic tests show a specific change that can be targeted, you might then be randomly assigned to receive either a targeted drug or standard maintenance chemotherapy. If no specific targetable changes are found, you might be considered for a different part of the study where immunotherapy is compared to standard maintenance chemotherapy.

You'll have regular hospital visits, tests, and scans to monitor your health and how well the treatment is working. The specific frequency of visits will depend on the treatment you receive. This study aims to monitor your progress over a long period. All treatments and tests directly related to the study will be provided.