Metastatic breast cancer continues to be a major cause of cancer death among women globally. In recent years, a better understanding of tumor biology, and the availability of high-throughput technologies has enabled the emergence of precision medicine bringing new expectations and giving rise to molecular screening programs worldwide. Recently, the MOSCATO trial has shown for the very first time that prospectively sequencing a large panel of genes and utilizing this information to guide treatment choices may improve the outcome of a subset of patients. Some institutions are implementing such strategy as part of the routine treatment decision-making process. However, SOLTI, as a collaborative Spanish network, runs AGATA, the first multi-institutional molecular screening program ever implemented in this country. Patient recruitment started in October 2014 and is expected to conclude in June 2017.
Up to 260 patients with metastatic breast cancer will be recruited in 10 participating sites in Spain. Mutation testing is performed prospectively in the genomic laboratories of Vall d´Hebron Institute of Oncology in Barcelona, 12 de Octubre University Hospital in Madrid, and the University Clinical Hospital of Valencia. Upon molecular characterization and collection of key clinical data, each case is reviewed by a multidisciplinary advisory board, which recommends potential experimental treatments, mainly in the context of clinical trials. During this pilot stage, our primary objective is to determine the success rate in including patients in trials based on their molecular profile. Additional aims are to identify technical and logistical barriers to the implementation of a nationwide program, describe the genomic profiles of the tumors, and assess patient outcomes. Retrospective gene expression (PAM50 + 110 genes and 20 miRNAs) and proteomic analysis (40 markers) will be performed to provide a more comprehensive molecular profile of the tumors that may help explain sensitivity or resistance to administered therapies. Data collected within this program is expected to generate hypotheses for further investigations directed to improve precision medicine.
Clinical trial identification
Legal entity responsible for the study
SOLTI Breast Cancer Research Group
Novartis, Mutua Madrileña, Instituto de Salud Carlos III
All authors have declared no conflicts of interest.