AURORA (BIG 14-01)
(public name: Metastatic Breast Cancer GPS)
The AURORA programme - Aiming to Understand the Molecular Aberrations in Metastatic Breast Cancer
Approximately 1 in 3 of all breast cancers will metastasise, meaning the cancer has spread to other parts of the body. Just as a GPS guidance system helps you locate and avoid traffic problems, finding the best route to your destination, the GPS programme aims to identify breakdowns (genetic aberrations) and to map the routes that cancer cells take to invade other organs. Knowing this, we can stop them, or change their route by choosing the best possible route to treatment.
The GPS programme helps us to understand both why breast cancer spreads (metastasises) and why some metastases respond poorly to standard treatment, while others respond very well. Whenever possible, patients participating in the GPS programme will be offered to participate in clinical trials testing new and promising drugs that target the specific genetic characteristics of their tumours. The hope is that the GPS programme will one day lead us both to better treatments and to cures for the women and men affected by metastatic disease.
Patients will have their tumour samples and blood tested for genetic aberrations using molecular screening. Molecular screening uses technology that can characterise cancer on the genetic level in great detail. A unique aspect of the GPS programme is that the genetic tests will be done on samples collected when patients were first diagnosed with breast cancer and on samples taken after the cancer metastasised. This information will enable us to:
1) analyse why some tumours respond poorly to treatment, 2) evaluate why some tumours respond exceptionally well to treatment, and 3) learn about the natural evolution of the disease.
Patients aged 18 and older, who have been newly diagnosed with metastatic breast cancer, for which they have received no more than one course of treatment. Participation requires primary and metastatic tumour tissue as well as blood to be available for genetic testing.
Overall recruitment goal: 1.000 patients
1) Targeted sequencing1 will be done for all patients (on samples collected when they were first diagnosed, on metastatic tumour samples and on blood) to test for genetic aberrations in a specific set of cancer-related genes.
2) If an aberration is found, a clinical trial testing a new treatment designed to target that aberration may be proposed to the patient. If no drug or clinical trial is available for an aberration, or if no aberration is found, the best available standard treatment will be proposed to the patient. All patients will be followed up every 6 months, for up to 10 years.
3) Whole exome sequencing2 will be done (on samples collected when they were first diagnosed, on metastatic tumour samples and on blood) to test for genetic aberrations for those patients whose tumours responded either exceptionally well or poorly to a treatment.
Recruitment of patients started in 2014
• Approximately 400 patients per year are expected to be recruited in this European collaboration.
• Recruitment is anticipated to be completed in 3 years.
• Patients will be followed for up to 10 years after enrolment.
Over 80 hospitals associated with 11 BIG research groups across Europe will participate in the programme.
Total budget = 24.624.000 € or 1.890 € per patient per year
AURORA is made possible in part by generous grants from the Breast Cancer Research Foundation®, the Fondation Cancer (Luxembourg), the National Lottery (Belgium), NIF Trust and individual donors. AURORA is carried out with the support of the Fund Friends of BIG, managed by the King Baudouin Foundation.
|ClinicalTrials.gov Identifier: NCT02102165|