BREAST: Edited by Fabrice AndreIssues in clinical research for metastatic breast cancerDogan, Semiha; Andre, Fabricea,b; Arnedos, Monicaa,bAuthor Information aINSERM Unit U981, Université Paris Sud, Gustave Roussy bDepartment of Medical Oncology, Gustave Roussy, Villejuif, France Correspondence to Monica Arnedos, Gustave Roussy, 114 Rue Edouard Vaillant, 94800 Villejuif, France. Tel: +33 1 42 11 43 71; fax: +33 1 42 11 52 74; e-mail: [email protected] Current Opinion in Oncology: November 2013 - Volume 25 - Issue 6 - p 625-629 doi: 10.1097/CCO.0000000000000018 Buy Metrics Abstract Purpose of review Technical advances and progresses in tumor biology hold promise for the advent of new anticancer agents. These changes are impacting the conduct and design of clinical trials. This review describes the changing landscape of clinical research in metastatic breast cancer (MBC). Recent findings Clinical trials in breast cancer that started between 2007 and 2011 were analyzed. In the metastatic setting, 72% (n = 479) of these studies evaluated targeted therapies and 21% (n = 139) conventional treatments. During this period, the number of phase II trials decreased over time, whereas biology-driven studies, although small in terms of absolute number, now represent 15% of the total. Nevertheless, genomic segments are too rare to allow conventional drug development and require changes in the way clinical trials are being done. Several options are being explored to address this challenge: develop large consortium, perform molecular screening in larger populations, develop clinical trials testing algorithm for treatment decision, and no longer drugs. Summary The landscape of clinical research in MBC is changing with the development of molecular medicine. Research institutions and cooperative groups will need to adapt to this changing landscape in clinical research. © 2013 Lippincott Williams & Wilkins, Inc.