Guidelines for the design of clinical studies for the development and validation of therapeutically relevant biomarkers and biomarker-based classification systems / Richard M. Simon -- Analytical aspects of biomarker immunoassays in cancer research / C. G. J. (Fred) Sweep, Chris M. G. Thomas and Manfred Schmitt -- Tissue microarrays: state-of-the-art, pitfalls, and promises / Chungyeul Kim and Soonmyung Paik -- Gene expression profiling with DNA microarrays / Michele De Bortoli and Nicoletta Biglia -- Assays for gene amplification / Chungyeul Kim, Yongkuk Song, and Soonmyung Paik -- Cell kinetics / Maria Grazia Daidone, Rosella Silvestrini, and Dino Amadori -- Urokinase-type plasminogen activator and PAI-1 / Michael J. Duffy -- Predictive value of c-erbb-2 for endocrine therapy and chemotherapy in breast cancer / Vered Stearns -- Erb-b-2 as a therapeutic target / Robert Mass -- The epidermal growth factor receptor pathway as a selective -- Molecular-targeting treatment in human breast cancer / Fortunato Ciardiello, Teresa Troiani, and Giampaolo Tortora -- P-53 as a prognostic and predictive indicator / Daniela Kandioler and Raimund Jakesz -- Occult metastatic cells in breast cancer patients / Stephan Braun, Julia Seeber, and Christian Marth -- Circulating HER-2/neu / Allan Lipton ... [et al.] -- Circulating vascular endothelial growth factor / Roberta Sarmiento ... [et al] -- Detection of early tumor dissemination in patients with breast cancer / Debra Hawes and Richard J. Cote -- New technologies/new markers/new challenges / Daniel F. Hayes and Giampietro Gasparini -- Index.