SOLTI Breast Cancer Molecular Screening Program (AGATA)

This is a prospective, multicenter, pilot study conducted in eight sites located in Spain. Up to 260 female or male patients, between 18-70 years with advanced or metastatic breast cancer will be screened. These patients will be about to receive, or receiving, or will have received treatment for their disease in either a clinical trial or the healthcare setting. Quality of life score according to ECOG scale ≤ 2 and a minimal life expectancy of 3 months. Upon signed inform consent and confirmation of eligibility criteria, tumor samples will be obtained from the patients either by biopsy of metastatic cancer or from archived tissue previously available at the site, and their genomic profile will be analyzed. It will be assessed the mutational status of a panel of genes considered relevant to the tumor biology and treatment. Detected variants /mutations in samples will not be classified according to their origin somatic or germline, since no normal paired DNA will be analyzed. Should any clinical trial match the patient's molecular profile, she/he will be offered to participate in it and the available samples left after sequencing will be supplied when a central confirmation would be requested. The patient's clinical data will be collected on a quarterly basis until death or consent withdrawal. Mutation testing will be carried out at three laboratories experienced in high-throughput sequencing techniques: the VHIO Cancer Genomics Core laboratory of Barcelona, at Genomics Laboratory of the Research Institute of the Doce de Octubre University Hospital of Madrid and at the Genomics laboratory of the University Clinical Hospital of Valencia. There is a need to join efforts, set standards and optimize procedures for the benefit of all patients, so that the opportunity to participate in a genomic screening program can be offered to the great majority of hospitals that lack the technology required for these tests.