title: Clinical and Molecular Methods in Drug Development: Neoadjuvant Systemic Therapy in Breast Cancer as a Model.
abstract: Neoadjuvant chemotherapy (NACT), neoadjuvant endocrine therapy (NAET), and neoadjuvant targeted therapy (NATT), more recently, have been adopted worldwide as standard of care in locally advanced and inoperable BC. These modalities, collectively called neoadjuvant systemic therapy (NAST), are also used for organ preservation and for mechanistic biological studies on drug response and resistance, drug development, and clinical trials. Furthermore, the response to NACT is a valuable indicator of long-term survival. In this work, the advantages and pitfalls of using NAST in BC for studying drug response and resistance for drug development and clinical trials are discussed as well as practical points on how to set up a NAST clinical trial in BC.
authors.affiliation: José de Mello Saúde, Avenida Do Forte Edifício Suécia III, Piso 1, Carnaxide, Lisbon, Portugal. Sofia.Braga@jmellosaude.pt.|Faculdade de Ciências Biomédicas e Medicina, Universidade do Algarve, Faro, Portugal. Sofia.Braga@jmellosaude.pt.
authors.forename: Sofia
authors.initials: S
authors.lastname: Braga
mesh_terms: D001706:Biopsy; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000378:metabolism / Q000473:pathology; D055808:Drug Discovery / Q000379:methods*; D006801:Humans; D007150:Immunohistochemistry; D033183:Interdisciplinary Communication; D008279:Magnetic Resonance Imaging; D020360:Neoadjuvant Therapy; D016133:Polymerase Chain Reaction; D049268:Positron-Emission Tomography; D012867:Skin / Q000473:pathology; D013194:Staining and Labeling; D016019:Survival Analysis
keywords: Immunohistochemistry; Metabolic response; Neoadjuvant breast cancer; Overall survival; Pathologic complete response; Polymerase chain reaction; Radiologic response; ki67 labeling